Data / Medical devices / United States / Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc.: FDA-registered device maker in Newark, DE, United States, 303 510(k) clearances and 3 PMA approvals
Siemens Healthcare Diagnostics Inc. is registered with the FDA (registration 2517506) in Newark, DE, United States. It lists 160 device types. The FDA files 303 510(k) clearances and 3 PMA approvals under its listings, the newest dated July 24, 2026. 180 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2517506
- Address
- 500 GBC DR, PO Box 6101, Newark, DE, United States, 19714
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- April 18, 1995
- Registered through
- 2027
- Brand names listed
- ADVIA, ADVIA 1650 HDL CHOLESTEROL ASSAY, ADVIA Centaur NT proBNPII (PBNPII), ADVIA Centaur NT-proBNP (PBNP), ADVIA Chemistry, ADVIA Chemistry A1c_E Pretreatment Buffer Kit, ADVIA Chemistry A1c_E Reagent (2x150 Kit), ADVIA Chemistry A1c_E Reagent (4x300 Kit) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 303.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 24, 2026 | K261364 | Atellica CH Acetaminophen 2 (ACTM) | LDP | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 27, 2026 | K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | CIG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 25, 2025 | K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| December 4, 2024 | K242685 | Atellica® CH Creatinine_3 (Crea3) | CGX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | MRR | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | NQD | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| September 24, 2023 | K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | NBC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 8, 2023 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | LEH | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 25, 2023 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | JGS | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 25, 2023 | K221605 | Emit® II Plus Buprenorphine Assay | DJG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 13, 2023 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| June 12, 2023 | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | CIG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 17, 2023 | K221119 | RCRP Flex reagent cartridge | DCN | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 26, 2022 | K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | PRI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 24, 2021 | K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | JFY | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 2, 2021 | K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay | PDJ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 17, 2019 | K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | MMI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 4, 2019 | K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | MMI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 13, 2018 | K173909 | Dimension Hemoglobin A1c Assay | PDJ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 25, 2017 | K170293 | Emit II Plus Cocaine Metabolite Assay | DIO | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 18, 2017 | K172910 | Emit II Plus Oxycodone Assay | DJG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 16, 2017 | K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | MRG | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 9, 2017 | K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | JFM | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 11, 2016 | K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | CDZ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 18, 2015 | K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 11, 2015 | K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator | JGS | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 20, 2015 | K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 4, 2015 | K150168 | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) | MLM | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 23, 2015 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive | DJG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| September 18, 2015 | K143720 | Dimension Vista MMB Assay | JHY | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| June 15, 2015 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 26, 2014 | K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | CEC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 27, 2014 | K132638 | DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE | CGX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 24, 2014 | K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | CGX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 2, 2014 | K133512 | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) | CDD | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 16, 2013 | K132664 | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | CJW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 5, 2013 | K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 22, 2013 | K130276 | DIMENSION EXL WITH LM SYSTEM | JJE | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 7, 2013 | K123677 | DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) | JIF | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 15, 2013 | K123321 | DIMENSION CHEMISTRY III CALIBRATORY | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 15, 2013 | K123320 | DIMENSION AMMONIA FLEX REAGENT CARTRIDGE | JIF | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 30, 2012 | K121994 | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR | CDD | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122323 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | CJO | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 23, 2012 | K121907 | DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR | CJO | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 22, 2011 | K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | JJE | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 4, 2011 | K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | NDW | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 7, 2011 | K102772 | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) | OAV | Substantially Equivalent | Siemens Heatlhcare Diagnostics, Inc. | accessdata.fda.gov |
| May 16, 2011 | K110303 | STRATUS CS ACUTE CARE D-DIMER | DAP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 18, 2011 | K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 | MOI | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 12, 2011 | K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 | LTK | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 6, 2011 | K100375 | DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 | NIG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 18, 2011 | K102779 | EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C | DJG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 16, 2011 | K103836 | ENZYME II CALIBRATOR | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 25, 2011 | K103612 | DIMENSION VISA ENZ 2 CAL | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 17, 2010 | K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | JIT | Substantially Equivalent | Siemens Corp. | accessdata.fda.gov |
| August 2, 2010 | K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | LDP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 9, 2010 | K101460 | LOCI 8 CALIBRATOR, MODEL KC 646 | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 19, 2010 | K093939 | ADVIA CHEMISTRY SALICYLATE REAGENT | DKJ | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 10, 2010 | K100289 | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 | KHS | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 5, 2010 | K100778 | DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 7, 2010 | K093441 | DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 | KXT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 12, 2010 | K093631 | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 | CDD | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 22, 2009 | K090330 | DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 | JFY | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 27, 2009 | K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | LOJ | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| March 30, 2009 | K083487 | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR | NRP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 27, 2009 | K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE | CGS | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 27, 2009 | K083462 | DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| February 26, 2009 | K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | KLI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 20, 2009 | K083579 | DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 8, 2009 | K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | LCP | Substantially Equivalent | Siemens Medical Solutions Diagnostics | accessdata.fda.gov |
| October 30, 2008 | K081857 | DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 | NRP | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082680 | LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| September 22, 2008 | K082645 | DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 | NBC | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| September 10, 2008 | K081789 | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 29, 2008 | K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | CGS | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| August 4, 2008 | K081319 | DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 7, 2008 | K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 3, 2008 | K081643 | DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 | MMI | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| July 2, 2008 | K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | JHM | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| June 25, 2008 | K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | DHX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 16, 2008 | K080578 | DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA | NBC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 21, 2008 | K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | JHM | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 3, 2008 | K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | JFY | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 12, 2007 | K072717 | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 7, 2007 | K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | JFM | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| November 13, 2007 | K071224 | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR | CDD | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 24, 2007 | K071811 | ETOH FLEX REAGENT CARTRIDGE (DF22) | DIC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 17, 2007 | K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM | NBC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 4, 2007 | K071767 | DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A | NBC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 3, 2007 | K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | JFY | Substantially Equivalent | Siemens Medical Solutions Diagnostics | accessdata.fda.gov |
| June 13, 2007 | K070853 | DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 | DIC | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 30, 2007 | K070552 | DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| March 23, 2007 | K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | DAP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| February 23, 2007 | K063754 | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 | DHA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 11, 2007 | K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | DEM | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 26, 2006 | K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | NQD | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 14, 2006 | K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | DLJ | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 14, 2006 | K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | DKB | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 6, 2006 | K062034 | DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) | JIX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 29, 2006 | K061839 | DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 | CIG | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 24, 2003 | P020027 | DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS | MTG | 41 | May 22, 2025 | accessdata.fda.gov |
| July 5, 2001 | P000021 | DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE | LTJ | 45 | May 22, 2025 | accessdata.fda.gov |
| October 2, 1996 | P920031 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | MKW | 3 | July 24, 2002 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 180.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | 99379 | Class III | Ongoing | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL | Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild ski | accessdata.fda.gov |
| May 7, 2026 | 98985 | Class II | Ongoing | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. | accessdata.fda.gov |
| March 18, 2026 | 98666 | Class II | Ongoing | Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. | Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine p | accessdata.fda.gov |
| November 12, 2024 | 95751 | Class II | Ongoing | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158 | Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the | accessdata.fda.gov |
| July 30, 2024 | 95116 | Class II | Ongoing | Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146 | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted. | accessdata.fda.gov |
| May 16, 2023 | 92461 | Class II | Ongoing | Aptio Automation Storage and Retrieval Module (SRM) | A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just place | accessdata.fda.gov |
| August 24, 2022 | 90872 | Class II | Ongoing | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A | Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed. | accessdata.fda.gov |
| August 17, 2022 | 90825 | Class II | Ongoing | Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57 | Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of | accessdata.fda.gov |
| July 18, 2022 | 90669 | Class II | Ongoing | Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456 | Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions. | accessdata.fda.gov |
| May 18, 2022 | 90387 | Class II | Terminated | Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/RE | Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inappropriate intervention for myocardial infarction | accessdata.fda.gov |
| January 28, 2022 | 89697 | Class II | Ongoing | Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic test | Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing. | accessdata.fda.gov |
| October 15, 2021 | 89008 | Class II | Terminated | Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body f | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays | accessdata.fda.gov |
| October 6, 2021 | 88865 | Class II | Ongoing | Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038 | The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions. | accessdata.fda.gov |
| February 3, 2021 | 87319 | Class II | Ongoing | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk fo | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA. | accessdata.fda.gov |
| August 25, 2020 | 86430 | Class II | Terminated | Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444 | Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well | accessdata.fda.gov |
| August 19, 2020 | 86374 | Class II | Terminated | Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068 | Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed | accessdata.fda.gov |
| July 24, 2020 | 86151 | Class II | Terminated | Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067 | Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples | accessdata.fda.gov |
| June 30, 2020 | 85980 | Class II | Terminated | DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the las | accessdata.fda.gov |
| May 4, 2020 | 85602 | Class II | Terminated | ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma f | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | accessdata.fda.gov |
| February 13, 2020 | 85037 | Class II | Terminated | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct b | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | accessdata.fda.gov |
| July 15, 2019 | 83384 | Class II | Terminated | Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in human se | Negative Bias with Lot EA9227. | accessdata.fda.gov |
| May 3, 2019 | 82980 | Class II | Terminated | ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative deter | A steady upward trend in blank (u) absorbance was observed | accessdata.fda.gov |
| December 12, 2018 | 81955 | Class II | Terminated | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination. | accessdata.fda.gov |
| October 16, 2018 | 81478 | Class II | Terminated | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of an | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future | accessdata.fda.gov |
| October 11, 2018 | 81433 | Class II | Terminated | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K | Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrog | accessdata.fda.gov |
| September 28, 2018 | 81278 | Class II | Terminated | Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension EXL 200 00630414593579; Dimension EXL with LM 00630414593500; Dimension EXL with LM with STM 00630414593593; Dimension Rx | Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock | accessdata.fda.gov |
| September 7, 2018 | 81237 | Class II | Terminated | Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimensi | There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots. | accessdata.fda.gov |
| July 16, 2018 | 80516 | Class II | Terminated | RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to pati | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the me | accessdata.fda.gov |
| April 19, 2018 | 80009 | Class II | Terminated | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. | The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. | accessdata.fda.gov |
| March 21, 2018 | 79784 | Class II | Terminated | Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205 | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial. | accessdata.fda.gov |
| January 30, 2018 | 79593 | Class II | Terminated | Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the | May produce erroneously low results from specific well sets. | accessdata.fda.gov |
| December 14, 2017 | 79468 | Class II | Terminated | Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase) | Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits. | accessdata.fda.gov |
| November 27, 2017 | 79413 | Class II | Terminated | Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples. | accessdata.fda.gov |
| November 9, 2017 | 79412 | Class II | Terminated | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) me | An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay. | accessdata.fda.gov |
| May 23, 2017 | 77381 | Class II | Terminated | Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER). | accessdata.fda.gov |
| March 21, 2017 | 76915 | Class II | Terminated | Dimension Troponin 1 (TNI) Flex reagent cartridge | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere. | accessdata.fda.gov |
| March 3, 2017 | 76690 | Class II | Terminated | Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15 percent in the ECREA result. | accessdata.fda.gov |
| February 23, 2017 | 76695 | Class III | Terminated | ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with Advia Chemistry Enzyme 2 Calibrator lots 6JD079 and 6MD042. | accessdata.fda.gov |
| December 16, 2016 | 76152 | Class II | Terminated | Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia meas | Siemens Healthcare Diagnostics has determined that Dimension AMM (DF119) flex reagent cartridge lots EB7180, FB7152, BA7194, EA7223, BA7250 do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay. | accessdata.fda.gov |
| September 29, 2016 | 75417 | Class II | Terminated | Aptio Automation Modules | Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. | accessdata.fda.gov |
| September 15, 2016 | 75484 | Class II | Terminated | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082. | accessdata.fda.gov |
| August 25, 2016 | 75256 | Class III | Terminated | Dimension Vista IRON Flex reagent cartridges | Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU). | accessdata.fda.gov |
| August 3, 2016 | 74987 | Class II | Terminated | Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets. | accessdata.fda.gov |
| June 17, 2016 | 74524 | Class II | Terminated | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples. | accessdata.fda.gov |
| May 5, 2016 | 76293 | Class III | Terminated | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use o | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots. | accessdata.fda.gov |
| March 17, 2016 | 73667 | Class II | Terminated | Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity an | accessdata.fda.gov |
| March 8, 2016 | 73594 | Class II | Terminated | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma. | Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased. | accessdata.fda.gov |
| February 16, 2016 | 73592 | Class II | Terminated | Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, pla | Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagen cartridges manufactured from specific mold cavities. | accessdata.fda.gov |
| February 9, 2016 | 73442 | Class II | Terminated | Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIRO method is an in vitro diagnostic test for the quantitative measurement of sirol | Siemens Healthcare Diagnostics has received customer complaints regarding QC shifts and imprecision after one day when using Dimension SIRO lot EB6064. They have confirmed SIRO lot # EB6064 does not meet the open well stability claim of 2 days. | accessdata.fda.gov |
| November 3, 2015 | 73080 | Class II | Terminated | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measuremen | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine stabilizer B2MIC. In the unlikely event that a patient result is generated, a suppressed result would be in conflict with the pati | accessdata.fda.gov |
| September 30, 2015 | 72399 | Class II | Terminated | Dimension Vista System (MG); Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. | Erroneous low results on a small number of reagent wells. There is the potential for under-recovery on certain wells for quality control (QC) and patient sample results. The under-recovery ranged from -0.3 mg/dL [0.12 mmol/L] to -1.6 mg/dL [0.66 mmol/L]; equivalent to a maximum negative bias of -88%. | accessdata.fda.gov |
| September 24, 2015 | 72392 | Class II | Terminated | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes mark | Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias. | accessdata.fda.gov |
| August 26, 2015 | 82345 | Class II | Terminated | syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple | Software Issues. | accessdata.fda.gov |
| July 23, 2015 | 71831 | Class II | Terminated | Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-Microglobulin in human serum, heparinized plasma, EDT | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination. | accessdata.fda.gov |
| July 15, 2015 | 71725 | Class II | Terminated | Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL respectively. | accessdata.fda.gov |
| June 30, 2015 | 71710 | Class II | Terminated | ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. | A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA Chemistry Systems Acetaminophen assay for certain lots. | accessdata.fda.gov |
| May 21, 2015 | 71315 | Class II | Terminated | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors. | accessdata.fda.gov |
| May 19, 2015 | 71362 | Class II | Terminated | CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data fro | Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system. | accessdata.fda.gov |
| May 11, 2015 | 71267 | Class II | Terminated | Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. | Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range. | accessdata.fda.gov |
| April 29, 2015 | 71204 | Class II | Terminated | EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory infor | System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports. | accessdata.fda.gov |
| April 20, 2015 | 71096 | Class II | Terminated | Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone in human serum and plasma on the Dimension Vista Sys | Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent volume in a Flex well. | accessdata.fda.gov |
| April 2, 2015 | 70913 | Class II | Terminated | Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL cl | Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as described may lead to a potential electrical hazard. The likelihood of potential clinical impact or injury due to this issue is extremely low. | accessdata.fda.gov |
| March 25, 2015 | 71273 | Class II | Terminated | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and other coagulation procedures requiring | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples with recoveries close to the medical decision points could exhibit a deviation up to 4 seconds for the normal range and up to 33% for the pathological range. | accessdata.fda.gov |
| February 24, 2015 | 70627 | Class II | Terminated | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the D | A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results. | accessdata.fda.gov |
| January 15, 2015 | 70385 | Class III | Terminated | N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and B | Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042. | accessdata.fda.gov |
| December 16, 2014 | 70078 | Class II | Terminated | ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and | Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat. | accessdata.fda.gov |
| November 24, 2014 | 69937 | Class II | Terminated | Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System. | Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected. | accessdata.fda.gov |
| November 5, 2014 | 69687 | Class II | Terminated | Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measurin | Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server. | accessdata.fda.gov |
| September 30, 2014 | 69434 | Class II | Terminated | Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemog | Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias. | accessdata.fda.gov |
| September 24, 2014 | 69372 | Class II | Terminated | siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epilep | Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range. | accessdata.fda.gov |
| August 28, 2014 | 69149 | Class II | Terminated | Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System. | Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this product. Siemens has observed drift from 3% to 12% at MMB concentrations across the assay range. Depending on quality control li | accessdata.fda.gov |
| August 19, 2014 | 69129 | Class II | Terminated | Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the | Siemens Healthcare Diagnostics has identified a task scheduler issue with the CentraLink" Data Management System, software version 14. The issue may cause the software to stop executing commands, including uploading validated results to the LIS. The issue is related to an internal software timer that overflows after 24 days. Automated rules triggered by task | accessdata.fda.gov |
| August 18, 2014 | 69063 | Class II | Terminated | Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG) | Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibratio | accessdata.fda.gov |
| August 14, 2014 | 69334 | Class II | Terminated | Dimension Vista HbA1c | In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percen | accessdata.fda.gov |
| July 16, 2014 | 68854 | Class II | Terminated | Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337 | The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator. | accessdata.fda.gov |
| July 15, 2014 | 68848 | Class II | Terminated | Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for | Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemist | accessdata.fda.gov |
| May 27, 2014 | 68400 | Class III | Terminated | Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids. | There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the sourc | accessdata.fda.gov |
| May 20, 2014 | 68394 | Class II | Terminated | syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. | Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review. | accessdata.fda.gov |
| April 14, 2014 | 68076 | Class II | Terminated | Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagn | A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. | accessdata.fda.gov |
| March 19, 2014 | 67787 | Class II | Terminated | Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements of CSA are use | A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient sample | accessdata.fda.gov |
| January 6, 2014 | 67235 | Class II | Terminated | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), | Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL). | accessdata.fda.gov |
| December 17, 2013 | 67030 | Class II | Terminated | Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. | An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result. | accessdata.fda.gov |
| December 5, 2013 | 67057 | Class II | Terminated | Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid | Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges. | accessdata.fda.gov |
| November 6, 2013 | 67027 | Class II | Terminated | Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments whic | The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC). | accessdata.fda.gov |
| October 30, 2013 | 66694 | Class II | Terminated | Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) with | Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.) | accessdata.fda.gov |
| October 7, 2013 | 66585 | Class II | Terminated | User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 | When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex Cartridge to process the user defined method. | accessdata.fda.gov |
| September 18, 2013 | 66363 | Class II | Terminated | Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the | Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples. | accessdata.fda.gov |
| September 17, 2013 | 66364 | Class II | Terminated | Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL inte | Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration. | accessdata.fda.gov |
| August 30, 2013 | 66267 | Class II | Terminated | Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay | Imprecision with certain lots | accessdata.fda.gov |
| August 13, 2013 | 68965 | Class II | Terminated | Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic f | May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS. | accessdata.fda.gov |
| July 1, 2013 | 65706 | Class II | Terminated | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the D | Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the assay range may lead to alterations in dosing. | accessdata.fda.gov |
| June 19, 2013 | 65607 | Class II | Terminated | Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixi | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samp | accessdata.fda.gov |
| June 5, 2013 | 65152 | Class II | Terminated | Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for | Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed. | accessdata.fda.gov |
| May 20, 2013 | 65408 | Class II | Terminated | Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids. | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1 | accessdata.fda.gov |
| May 10, 2013 | 65147 | Class II | Terminated | syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC cap | Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS. | accessdata.fda.gov |
| May 6, 2013 | 65131 | Class II | Terminated | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module | Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in | accessdata.fda.gov |
| April 25, 2013 | 65051 | Class II | Terminated | Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measure | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. | accessdata.fda.gov |
| April 22, 2013 | 65409 | Class II | Terminated | HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system | Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed. | accessdata.fda.gov |
| March 11, 2013 | 63804 | Class II | Terminated | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT). | Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high. | accessdata.fda.gov |
| February 27, 2013 | 64570 | Class III | Terminated | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may c | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Immunoassay, Amphetamine
- All makers of Alkaline Picrate, Colorimetry, Creatinine
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Enzyme Immunoassay, Carbamazepine
- All makers of Enzyme Immunoassay, Gentamicin
- All makers of System, Test, C-Reactive Protein
Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.