Data / Medical devices / United States / Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc.: FDA-registered device maker in Tarrytown, NY, United States, 354 510(k) clearances and 17 PMA approvals
Siemens Healthcare Diagnostics Inc. is registered with the FDA (registration 2432235) in Tarrytown, NY, United States. It lists 247 device types. The FDA files 354 510(k) clearances and 17 PMA approvals under its listings, the newest dated August 10, 2026. 129 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2432235
- Address
- 511 Benedict Ave, Tarrytown, NY, United States, 10591
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- December 20, 1977
- Registered through
- 2027
- Brand names listed
- 248 BG System, 3gAllergy Specific Allergens: Basil (F269), Cacao (F93),, 560 Hematology System, 600 Series Blood Gas, ACTH Control Module (ACT QC), ADIVA CENTAUR CP ANALYZER, ADVIA, ADVIA 120 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 354.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 10, 2026 | K253528 | Atellica IM CA 19-9 II | NIG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| 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 |
| February 6, 2026 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 5, 2026 | K251630 | Atellica IM Total PSA II (tPSAII) | LTJ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 16, 2025 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | OVK | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
| December 4, 2025 | K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | JNL | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 17, 2025 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | JZO | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| June 20, 2025 | K242981 | Atellica IM Thyroglobulin (Tg) | MSW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | 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 |
| July 25, 2024 | K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | MMI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 21, 2024 | K232946 | Yumizen H2500 | GKZ | Substantially Equivalent | HORIBA ABX SAS | accessdata.fda.gov |
| April 4, 2024 | K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 13, 2024 | K233946 | IMMULITE® 2000 BR-MA | MOI | Substantially Equivalent | Siemens Healthcare Diagnostics Products, Ltd. | 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 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 |
| June 2, 2023 | K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | PQO | 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 |
| November 24, 2021 | K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | JFY | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 20, 2021 | DEN190056 | ADVIA Centaur Enhanced Liver Fibrosis (ELF) | QQB | Unknown | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 16, 2021 | K193397 | ADVIA Centaur® Digoxin assay | KXT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 13, 2021 | K200210 | ADVIA Centaur® Total hCG assay | DHA | 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 29, 2020 | K200509 | ADVIA Centaur Vitamin D Total (VitD) | MRG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 13, 2020 | K200215 | ADVIA Centaur CEA Assay | DHX | Substantially Equivalent | Siemens Healthcare Disgnostics, Inc. | accessdata.fda.gov |
| April 6, 2020 | K200199 | ADVIA Centaur CA 125II | LTK | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 27, 2020 | K192240 | RAPIDPoint 500e Blood Gas System | CHL | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 13, 2020 | K193489 | ADVIA Centaur BR | MOI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 15, 2020 | K193493 | ADVIA Centaur Total IgE (tIgE) | DGC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 25, 2019 | K192788 | ADVIA Centaur Cortisol (COR) | JFT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 22, 2019 | K192777 | ADVIA Centaur CA 15-3 assay | MOI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 30, 2019 | K192790 | Atellica IM Total hCG (ThCG) | DHA | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 28, 2019 | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | CDZ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 2, 2019 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay | GGT | Substantially Equivalent | Axis-Shield Diagnostics Limited | accessdata.fda.gov |
| July 30, 2019 | K191454 | Atellica CH Amylase_2 (AMY_2) | JFJ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 17, 2019 | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | QFO | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 21, 2018 | K182012 | ADVIA Centaur Calcitonin (CALCT) assay | JKR | Substantially Equivalent | Axis-Shield Diagnostics Limited | accessdata.fda.gov |
| August 23, 2018 | K181334 | ADVIA Centaur Herpes-2 IgG | MYF | Substantially Equivalent | Biokit, S.A. | accessdata.fda.gov |
| August 23, 2018 | K181333 | ADVIA Centaur Herpes-1 IgG | MXJ | Substantially Equivalent | Biokit, S.A. | accessdata.fda.gov |
| July 30, 2018 | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | LFZ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 16, 2018 | K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | PMT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 12, 2018 | K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | MMI | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 25, 2018 | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | NDY | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 12, 2018 | K172201 | Atellica IM Folate Assay | CGN | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 27, 2017 | K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | CDD | Substantially Equivalent | Axis-Shield Diagnostics, Ltd. | accessdata.fda.gov |
| October 18, 2017 | K172910 | Emit II Plus Oxycodone Assay | DJG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171642 | Atellica IM Ferritin Assay | DBF | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 11, 2017 | K162977 | ADVIA 2120i, ADVIA 2120 | GKZ | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 23, 2017 | K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | CEW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 9, 2017 | K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | JFM | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 9, 2017 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) | JGS | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 19, 2017 | K162399 | Atellica CH Magnesium (Mg) | JGJ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 17, 2016 | K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | JIT | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| November 15, 2016 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | CGX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| October 13, 2016 | K161964 | ADVIA Centaur HAV IgM Assay | LOL | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| September 7, 2016 | K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | CGS | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 4, 2016 | K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | NHX | Substantially Equivalent | Axis-Shield Diagnostics Limited | accessdata.fda.gov |
| July 26, 2016 | K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | CDD | Substantially Equivalent | Axis-Shield Diagnostics Limited | accessdata.fda.gov |
| June 29, 2016 | K151986 | ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material | CDZ | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 31, 2016 | K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 27, 2016 | K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | LEH | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 3, 2016 | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | JZO | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 26, 2016 | K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH | accessdata.fda.gov |
| January 11, 2016 | K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | Substantially Equivalent | Siemens Healthcare Diagnostic Products GmbH | 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 |
| September 29, 2015 | K150654 | Cholesterol | CHH | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| July 17, 2015 | K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 1, 2015 | K150403 | ADVIA Centaur TSH3-Ultra | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 22, 2015 | K141999 | ADVIA CENTAUR TSH | JLW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 13, 2015 | K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| January 27, 2015 | K143680 | ADVIA Centaur IgE Master Curve Material | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 23, 2014 | K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 5, 2014 | K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| December 5, 2014 | K142758 | ADVIA Centaur HAV total assay | LOL | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 17, 2014 | K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | KQO | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 29, 2014 | K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| July 24, 2014 | K133156 | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA | MRG | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 28, 2014 | K132801 | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY | DHB | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 31, 2014 | K140505 | ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 10, 2014 | K140267 | ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| February 5, 2014 | K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | CEW | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| January 24, 2014 | K131307 | ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR | LCP | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| November 22, 2013 | K133067 | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | CDT | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | 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 |
| September 13, 2013 | K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | CEC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 12, 2013 | K131536 | IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL | JJX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| April 19, 2013 | K122539 | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | CHL | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| April 4, 2013 | K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | NHX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| March 21, 2013 | K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | CEW | 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 |
| December 20, 2012 | K123046 | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR | DFC | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| August 14, 2012 | K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | JIS | Substantially Equivalent | Randox Laboratories Limited | 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 |
|---|---|---|---|---|---|---|
| May 11, 2026 | P250026 | Atellica IM free PSA II (fPSAII) | MTG | 0 | May 11, 2026 | accessdata.fda.gov |
| December 3, 2025 | P240021 | Atellica IM Total PSA II (tPSAII) | MTF | 1 | August 26, 2026 | accessdata.fda.gov |
| July 14, 2021 | P200017 | ADVIA Centaur Anti-HBe2 (aHBe2) assay | SEI | 4 | October 17, 2025 | accessdata.fda.gov |
| May 16, 2014 | P110041 | ADVIA CENTAUR HBSAGII | LOM | 17 | October 17, 2025 | accessdata.fda.gov |
| January 20, 2012 | P100039 | ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL | SEI | 17 | October 17, 2025 | accessdata.fda.gov |
| October 11, 2011 | P090024 | ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL | LOM | 13 | October 17, 2025 | accessdata.fda.gov |
| May 11, 2007 | P060005 | IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS | MTG | 21 | September 22, 2026 | accessdata.fda.gov |
| May 26, 2005 | P030049 | ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL | LOM | 14 | March 11, 2021 | accessdata.fda.gov |
| March 7, 2005 | P040017 | ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS | LOL | 0 | March 7, 2005 | accessdata.fda.gov |
| December 22, 2004 | P040018 | ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS | LOL | 0 | December 22, 2004 | accessdata.fda.gov |
| December 22, 2004 | P040004 | ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS | SEI | 20 | March 29, 2022 | accessdata.fda.gov |
| December 22, 2004 | P030056 | ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS | MZO | 18 | April 27, 2021 | accessdata.fda.gov |
| August 6, 2004 | P030040 | ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS | SEI | 23 | October 17, 2025 | accessdata.fda.gov |
| November 9, 2001 | P010007 | IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP | LOK | 22 | September 22, 2026 | accessdata.fda.gov |
| September 8, 2000 | P990055 | BAYER IMMUNO 1 COMPLEXED PSA ASSAY | NAF | 28 | July 16, 2025 | accessdata.fda.gov |
| December 22, 1995 | P950021 | ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY | MTG | 29 | July 16, 2025 | accessdata.fda.gov |
| September 29, 1995 | P930036 | ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS | LOK | 25 | May 11, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI. Newest 100 of 129.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2026 | 99726 | Class II | Ongoing | Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223 | The potential for falsely elevated results. | accessdata.fda.gov |
| July 6, 2026 | 99389 | Class II | Ongoing | Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic | Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures. | accessdata.fda.gov |
| June 8, 2026 | 99214 | Class II | Ongoing | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. | accessdata.fda.gov |
| February 23, 2026 | 98498 | Class II | Ongoing | Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536 | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this | accessdata.fda.gov |
| January 20, 2026 | 98370 | Class II | Ongoing | Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL. | accessdata.fda.gov |
| August 11, 2025 | 97398 | Class II | Ongoing | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. | Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. | accessdata.fda.gov |
| June 4, 2025 | 97037 | Class II | Ongoing | ADVIA 120/2120/2120i SETpoint Calibrator | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. | accessdata.fda.gov |
| May 22, 2025 | 96952 | Class II | Ongoing | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300 | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride. | accessdata.fda.gov |
| March 11, 2025 | 96440 | Class II | Ongoing | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. | Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. | accessdata.fda.gov |
| November 4, 2024 | 95644 | Class II | Ongoing | Atellica CI Analyzer. Catalog Numbers: 10947347. | Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the s | accessdata.fda.gov |
| October 21, 2024 | 95666 | Class II | Ongoing | Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635 | Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent. | accessdata.fda.gov |
| October 21, 2024 | 95626 | Class II | Ongoing | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Ki | accessdata.fda.gov |
| August 21, 2024 | 95259 | Class II | Ongoing | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) | Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer. | accessdata.fda.gov |
| August 15, 2024 | 95218 | Class II | Ongoing | Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers | Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously dep | accessdata.fda.gov |
| July 29, 2024 | 95112 | Class II | Ongoing | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 | The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. | accessdata.fda.gov |
| March 13, 2024 | 94260 | Class II | Ongoing | Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer Siemens Material Number (SMN): 11 | Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results. | accessdata.fda.gov |
| February 7, 2024 | 94021 | Class II | Ongoing | DCA Systems HbA1c Reagent Kit | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Po | accessdata.fda.gov |
| January 24, 2024 | 93939 | Class II | Ongoing | Atellica IM Erythropoietin (EPO) Assay (100 Test) | Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots. | accessdata.fda.gov |
| December 15, 2023 | 93782 | Class II | Ongoing | Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry | Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. | accessdata.fda.gov |
| August 8, 2023 | 92971 | Class II | Ongoing | ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests) | There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge. | accessdata.fda.gov |
| July 25, 2023 | 92808 | Class II | Ongoing | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid | There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems. | accessdata.fda.gov |
| July 10, 2023 | 92800 | Class II | Ongoing | Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SM | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC) | accessdata.fda.gov |
| April 5, 2023 | 92179 | Class II | Ongoing | ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Numb | Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias | accessdata.fda.gov |
| March 16, 2023 | 92059 | Class II | Ongoing | Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma | There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. | accessdata.fda.gov |
| January 30, 2023 | 91677 | Class II | Ongoing | Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system SMN: 10700795 (DF207) | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential orga | accessdata.fda.gov |
| January 27, 2023 | 91665 | Class II | Ongoing | Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632 | Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results | accessdata.fda.gov |
| December 7, 2022 | 91310 | Class II | Ongoing | IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples | accessdata.fda.gov |
| September 19, 2022 | 90900 | Class II | Ongoing | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy. | accessdata.fda.gov |
| June 28, 2022 | 90559 | Class II | Ongoing | Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples. | Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test. | accessdata.fda.gov |
| April 13, 2022 | 90153 | Class II | Ongoing | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 | Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results | accessdata.fda.gov |
| February 22, 2022 | 89900 | Class II | Ongoing | IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6] | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. | accessdata.fda.gov |
| February 9, 2022 | 89740 | Class II | Ongoing | Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. | accessdata.fda.gov |
| December 1, 2021 | 89211 | Class II | Terminated | Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635 | 2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L | accessdata.fda.gov |
| November 18, 2021 | 89160 | Class II | Ongoing | Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 | (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expi | accessdata.fda.gov |
| September 20, 2021 | 88784 | Class II | Ongoing | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 | The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention. | accessdata.fda.gov |
| May 18, 2021 | 88086 | Class II | Terminated | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch | ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result | accessdata.fda.gov |
| May 13, 2021 | 88056 | Class II | Ongoing | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000 | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay. | accessdata.fda.gov |
| May 4, 2021 | 87953 | Class II | Ongoing | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results | accessdata.fda.gov |
| March 5, 2021 | 87488 | Class II | Ongoing | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11 | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | accessdata.fda.gov |
| March 2, 2021 | 87590 | Class II | Terminated | BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. | accessdata.fda.gov |
| December 2, 2020 | 86970 | Class II | Terminated | Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids | Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results | accessdata.fda.gov |
| November 23, 2020 | 86900 | Class II | Ongoing | ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA | Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers. | accessdata.fda.gov |
| October 26, 2020 | 86718 | Class II | Terminated | Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 | Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values | accessdata.fda.gov |
| September 22, 2020 | 86504 | Class II | Ongoing | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number ( | Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of gl | accessdata.fda.gov |
| June 5, 2020 | 85844 | Class II | Terminated | ADVIA Chemistry Calibrator | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH. | accessdata.fda.gov |
| May 15, 2020 | 85737 | Class II | Terminated | (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: a | Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review | accessdata.fda.gov |
| May 7, 2020 | 85687 | Class II | Ongoing | Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 | Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers. | accessdata.fda.gov |
| February 27, 2020 | 85268 | Class II | Terminated | Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower | Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the | accessdata.fda.gov |
| February 14, 2020 | 85020 | Class II | Terminated | Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use. | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. | accessdata.fda.gov |
| February 5, 2020 | 84947 | Class II | Terminated | IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid | Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for ho | accessdata.fda.gov |
| January 12, 2020 | 84788 | Class II | Ongoing | Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 | Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results. | accessdata.fda.gov |
| January 6, 2020 | 84823 | Class II | Terminated | Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using | A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired. | accessdata.fda.gov |
| December 20, 2019 | 84768 | Class II | Terminated | ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as a | Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product. | accessdata.fda.gov |
| December 18, 2019 | 84612 | Class II | Terminated | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology. | accessdata.fda.gov |
| November 19, 2019 | 84413 | Class II | Terminated | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay. | Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery. | accessdata.fda.gov |
| October 11, 2019 | 84281 | Class II | Terminated | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on c | On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids | accessdata.fda.gov |
| September 23, 2019 | 83946 | Class II | Terminated | Atellica CH 930 Analyzer | Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. | accessdata.fda.gov |
| August 15, 2019 | 83655 | Class II | Terminated | Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 | Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 | accessdata.fda.gov |
| July 30, 2019 | 83529 | Class II | Terminated | Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens | Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below | accessdata.fda.gov |
| July 10, 2019 | 83349 | Class II | Terminated | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation. | accessdata.fda.gov |
| June 27, 2019 | 83311 | Class II | Terminated | N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539 | Iincreased (falsely elevated) Albumin results compared to expected results | accessdata.fda.gov |
| March 7, 2019 | 82602 | Class II | Terminated | Atellica IM 1300 Analyzer, Material Number 11066001 | There were multiple issues identified in the system software which required an update. | accessdata.fda.gov |
| September 26, 2018 | 81380 | Class II | Terminated | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of c | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime | accessdata.fda.gov |
| August 14, 2018 | 81047 | Class II | Terminated | APTIO INPUT/OUTPUT MODULE | The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality. | accessdata.fda.gov |
| June 29, 2018 | 80774 | Class II | Terminated | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1 | accessdata.fda.gov |
| March 27, 2018 | 79932 | Class II | Terminated | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. | accessdata.fda.gov |
| March 12, 2018 | 79699 | Class III | Terminated | Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 | Incorrect calibrator level listed in qualitative calibration steps | accessdata.fda.gov |
| February 26, 2018 | 79683 | Class II | Terminated | Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens. | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers | accessdata.fda.gov |
| January 2, 2018 | 79505 | Class II | Terminated | Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere. | accessdata.fda.gov |
| December 18, 2017 | 79496 | Class II | Ongoing | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests) | In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays. | accessdata.fda.gov |
| October 17, 2017 | 79053 | Class II | Terminated | BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in v | The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use). | accessdata.fda.gov |
| June 29, 2017 | 79225 | Class II | Terminated | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories) | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. | accessdata.fda.gov |
| February 2, 2017 | 76485 | Class II | Terminated | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspir | Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu. | accessdata.fda.gov |
| January 31, 2017 | 76770 | Class II | Terminated | SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism. | Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8C, as published in the Instructions for Use (IFU). Adjustors stored at 2-8C after 14 days may show a bias in patient samples and quality control falling outside of published ranges. Lookback not recommende | accessdata.fda.gov |
| January 11, 2017 | 76251 | Class II | Terminated | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973, IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance. | accessdata.fda.gov |
| December 21, 2016 | 76124 | Class II | Terminated | IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative | Negative bias with IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL. | accessdata.fda.gov |
| November 29, 2016 | 75942 | Class II | Terminated | CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within | There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order. | accessdata.fda.gov |
| November 22, 2016 | 75837 | Class II | Terminated | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- | Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid Hormone) (iPTH) assay kit lot 320. Siemens has confirmed that IMMULITE 2000/IMMULITE 2000 XPi Intact PTH kit lot 320 can exhibit an average negative bias of up to -39% at iPTH concentrations <20 pg/mL with serum and EDTA patient samples vs. a reference ki | accessdata.fda.gov |
| November 18, 2016 | 75798 | Class II | Terminated | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS | Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use. | accessdata.fda.gov |
| October 21, 2016 | 75652 | Class II | Terminated | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date | accessdata.fda.gov |
| October 7, 2016 | 75487 | Class II | Terminated | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c | Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for Direct Bilirubin measurement. | accessdata.fda.gov |
| August 30, 2016 | 75090 | Class II | Terminated | IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog | Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above. | accessdata.fda.gov |
| August 24, 2016 | 75037 | Class II | Terminated | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagn | Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms. | accessdata.fda.gov |
| July 20, 2016 | 74830 | Class II | Terminated | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemi | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFC | accessdata.fda.gov |
| May 26, 2016 | 74309 | Class II | Terminated | ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This sy | Eight (8) issues were identified which may affect the results generated by the system software version. | accessdata.fda.gov |
| April 28, 2016 | 74162 | Class II | Terminated | ADVIA Centaur XPT Immunoassay System | The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language o | accessdata.fda.gov |
| April 15, 2016 | 73995 | Class II | Terminated | IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma. | 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment solution when using the pretreatment solution (LGFA) contained in the kit. | accessdata.fda.gov |
| March 30, 2016 | 73801 | Class III | Terminated | ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests perfo | The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide. | accessdata.fda.gov |
| March 10, 2016 | 73588 | Class II | Terminated | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories | Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the f | accessdata.fda.gov |
| March 7, 2016 | 73635 | Class II | Terminated | ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems. | Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932. | accessdata.fda.gov |
| January 14, 2016 | 73099 | Class II | Terminated | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 1 | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely sh | accessdata.fda.gov |
| November 19, 2015 | 72752 | Class II | Terminated | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay. | accessdata.fda.gov |
| October 7, 2015 | 72391 | Class II | Terminated | ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of bot | Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fai | accessdata.fda.gov |
| August 28, 2015 | 72104 | Class II | Terminated | ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. | ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls befor | accessdata.fda.gov |
| May 6, 2015 | 71363 | Class II | Terminated | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitativ | IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label. | accessdata.fda.gov |
| April 9, 2015 | 71006 | Class II | Terminated | IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases. | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values. | accessdata.fda.gov |
| March 23, 2015 | 70835 | Class II | Terminated | ADVIA Chemistry Lipase Reagent, Catalog Number B01-4840-01 REF: 01984894. | Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry Lipase outlier results when running with Triglycerides, Triglycerides_2, Triglycerides_c, Cholesterol concentrated, and DLDL reagents. | accessdata.fda.gov |
| February 11, 2015 | 70591 | Class II | Terminated | ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on | Siemens Healthcare Diagnostics has confirmed an issue with ADVIA Chemistry XPT software version 1.0.2. The system may cause samples to remain in an Inprocess state. Test results on a sample that is held Inprocess will not transmit to the LIS. Manual intervention is necessary to complete the processing of the samples that are held Inprocess. | accessdata.fda.gov |
| January 19, 2015 | 70410 | Class II | Terminated | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Info | Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation. | accessdata.fda.gov |
| October 27, 2014 | 69718 | Class II | Terminated | Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). | accessdata.fda.gov |
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Updated October 1, 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.