Data / Medical devices / United States / Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc: FDA-registered device maker in East Walpole, MA, United States, 63 510(k) clearances
Siemens Healthcare Diagnostics Inc is registered with the FDA (registration 3002637618) in East Walpole, MA, United States. It lists 59 device types. The FDA files 63 510(k) clearances under its listings, the newest dated February 6, 2026. 35 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002637618
- Address
- Point Of Care Headquarters 333 Coney St, East Walpole, MA, United States, 02032
- Owner or operator
- SIEMENS HEALTHCARE DIAGNOSTICS INC. (9096044)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- June 16, 1998
- Registered through
- 2026
- Brand names listed
- 248 BG System, 800 SERIES, ADVIA Centaur B-type Natriuretic Peptide (BNP), ADVIA Centaur BR Assay (BR), ADVIA Centaur Cortisol (Cor), ADVIA Centaur Digoxin (DIG), ADVIA Centaur Follicle Stimulating Hormone Master Curve Material (FSH MCM), ADVIA Centaur Hepatitis A IgM (aHAVM) 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | JLW | Substantially Equivalent | 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 |
| May 29, 2020 | K200509 | ADVIA Centaur Vitamin D Total (VitD) | MRG | 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 |
| October 13, 2016 | K161964 | ADVIA Centaur HAV IgM Assay | LOL | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | 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 |
| 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 |
| April 19, 2013 | K122539 | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | CHL | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 12, 2012 | K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | JIX | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. | accessdata.fda.gov |
| May 3, 2012 | K113216 | RAPIDPOINT 500 BLOOD GAS ANALYER | KHP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| August 15, 2011 | K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN | MQM | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| May 16, 2011 | K110303 | STRATUS CS ACUTE CARE D-DIMER | DAP | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| October 9, 2009 | K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 | JIL | Substantially Equivalent | Siemens Healthcare Diagnostics | accessdata.fda.gov |
| June 27, 2008 | K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | MQM | Substantially Equivalent | Siemens Medical Solutions Diagnostics | accessdata.fda.gov |
| October 9, 2007 | K071466 | DCA VANTAGE, MODEL 5075 | LCP | Substantially Equivalent | Siemens Medical Solutions Diagnostics | 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 |
| March 23, 2007 | K063356 | STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK | DAP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 28, 2006 | K063276 | CLINITEK ADVANTUS, MODEL 1420 | JIL | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| December 26, 2006 | K062924 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK | NQD | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 4, 2006 | K060369 | STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK | NQD | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 6, 2006 | K060548 | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK | DHA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 8, 2005 | K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. | JHX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| August 17, 2005 | K051597 | STRATUS CS D-DIMER | DAP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 22, 2005 | K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS | NBC | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| December 23, 2003 | K032563 | CLINITEST HCG PREGNANCY TEST | JHI | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| December 17, 2003 | K031560 | BAYER RAPIDLAB 1200 SYSTEM | CHL | Substantially Equivalent | Bayer Healthcare, LLC | accessdata.fda.gov |
| November 27, 2002 | K022977 | STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C | DAP | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| July 17, 2002 | K020616 | BAYER RAPIDPOINT 405 SYSTEM | GKR | Substantially Equivalent | Bayer Diagnostics Corp. | accessdata.fda.gov |
| July 5, 2002 | K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | JFY | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| September 11, 2001 | K012233 | STRATUS CS TROPONIN I CALIBRATOR | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| January 25, 2001 | K003696 | STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD | DHA | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 19, 2000 | K002738 | BAYER RAPIDPOINT 400 SYSTEM | CHL | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| November 24, 1999 | K992257 | NEW MULTIPLES REAGENT STRIPS | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| November 12, 1999 | K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| January 13, 1999 | K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK | JHX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| December 14, 1998 | K984065 | STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK | DDR | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| May 26, 1998 | K981099 | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK | JHX | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 27, 1998 | K981098 | STRATUS CS CARDIAC TROPONIN I TESTPAK | MMI | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 16, 1998 | K981097 | STRATUS CS CKMB CALPAK | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| April 15, 1998 | K981101 | STRATUS CS MYO CALPAK | JIT | Substantially Equivalent | Dade Behring, Inc. | accessdata.fda.gov |
| September 9, 1997 | K972706 | CLINITEK MICROALBUMIN REAGENT STRIPS | CJG | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| April 8, 1997 | K970956 | CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 | JJY | Substantially Equivalent | Chiron Diagnostics Corp. | accessdata.fda.gov |
| September 27, 1996 | K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | JIR | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| July 26, 1996 | K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | GLK | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| July 5, 1996 | K960888 | CHEK-STIX U.T.I. SELF-TEST | JMT | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
| June 24, 1996 | K962021 | CIBA CORNING 348 SYSTEM | CHL | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| July 14, 1995 | K952516 | PRO-VENT, LINE DRAW, PULSATOR | JKA | Substantially Equivalent | Smiths Industries Medical Systems, Inc. | accessdata.fda.gov |
| May 5, 1995 | K951361 | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C | LCP | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| October 31, 1994 | K943780 | NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) | JJW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| July 19, 1994 | K940971 | AMES DCA 2000 HEMOGLOBIN ALC CONTROLS | LCP | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| February 3, 1994 | K935830 | CIBA CORNING 248 PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| January 3, 1994 | K934907 | 860 MEASURMENT SYSTEM | CHL | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| August 19, 1993 | K932674 | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM | KQO | Substantially Equivalent | Miles Inc., Dental Products | accessdata.fda.gov |
| May 11, 1993 | K931467 | CHEK-STIX CONTROL STRIPS FOR URINALYSIS | JJW | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| November 22, 1991 | K914619 | CVM | JJY | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| September 5, 1991 | K911625 | AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM | LCP | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| February 11, 1991 | K905396 | HEMASTIX REAGENT STRIPS | JIO | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| January 14, 1987 | K870036 | BAYER HEALTHCARE RAPIDQC PLUS | JJS | Substantially Equivalent | Ciba Corning Diagnostics Corp. | accessdata.fda.gov |
| March 7, 1983 | K830223 | FECAL OCCULT SLIDE TEST KIT | KHE | Substantially Equivalent | Cambridge Chemical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | 98680 | Class II | Ongoing | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515 | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a | accessdata.fda.gov |
| July 7, 2025 | 97180 | Class II | Ongoing | epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observe | accessdata.fda.gov |
| June 26, 2025 | 97209 | Class II | Ongoing | RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnost | accessdata.fda.gov |
| March 31, 2025 | 96631 | Class II | Ongoing | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. | Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTn | accessdata.fda.gov |
| March 19, 2025 | 96539 | Class II | Ongoing | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Confi | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. | accessdata.fda.gov |
| September 24, 2024 | 95504 | Class II | Ongoing | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias | accessdata.fda.gov |
| May 17, 2024 | 94704 | Class II | Ongoing | Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint 500e Bloo | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to | accessdata.fda.gov |
| October 26, 2023 | 93473 | Class II | Ongoing | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813 | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresho | accessdata.fda.gov |
| October 19, 2023 | 93388 | Class II | Ongoing | epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occur | accessdata.fda.gov |
| September 26, 2023 | 93240 | Class II | Ongoing | RAPIDPOINT 500e Blood Gas System | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to i | accessdata.fda.gov |
| June 1, 2023 | 92537 | Class II | Ongoing | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. | accessdata.fda.gov |
| December 12, 2022 | 91639 | Class II | Ongoing | epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | accessdata.fda.gov |
| June 1, 2022 | 90432 | Class II | Ongoing | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 107365 | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. | accessdata.fda.gov |
| August 28, 2020 | 86378 | Class II | Terminated | Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/ | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia. | accessdata.fda.gov |
| May 27, 2020 | 85750 | Class II | Terminated | RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 | The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. | accessdata.fda.gov |
| May 29, 2019 | 82990 | Class II | Terminated | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagn | Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. | accessdata.fda.gov |
| April 10, 2017 | 76981 | Class II | Terminated | RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivativ | Potential Patient Demographic Error with Blank Patient ID Field | accessdata.fda.gov |
| September 2, 2016 | 75108 | Class III | Terminated | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge | accessdata.fda.gov |
| August 11, 2016 | 74910 | Class II | Terminated | Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381, 10339634 | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | accessdata.fda.gov |
| July 5, 2016 | 74564 | Class III | Terminated | Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood ga | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States | accessdata.fda.gov |
| June 22, 2016 | 74534 | Class II | Terminated | Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SM | Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours. | accessdata.fda.gov |
| November 11, 2015 | 72570 | Class II | Terminated | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071 | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems | accessdata.fda.gov |
| August 24, 2015 | 72044 | Class II | Terminated | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system t | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results | accessdata.fda.gov |
| July 28, 2015 | 71840 | Class II | Terminated | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, | When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient. | accessdata.fda.gov |
| January 22, 2015 | 70287 | Class II | Terminated | Siemens Healthcare Caps for capillary 100 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601 | Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary | accessdata.fda.gov |
| December 30, 2014 | 70203 | Class II | Terminated | RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory t | Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl. | accessdata.fda.gov |
| May 23, 2014 | 68437 | Class II | Terminated | RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoi | RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) | accessdata.fda.gov |
| May 22, 2014 | 68353 | Class III | Terminated | Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network | RAPIDComm 5.0 Screen Layout will display incorrect test names | accessdata.fda.gov |
| February 26, 2013 | 67930 | Class III | Terminated | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | accessdata.fda.gov |
| November 21, 2012 | 63809 | Class II | Terminated | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for uri | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | accessdata.fda.gov |
| September 17, 2012 | 66166 | Class II | Terminated | Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives i | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | accessdata.fda.gov |
| October 30, 2009 | 53541 | Not yet classified | Terminated | RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.1. The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and m | Software: Reference sensor failure may result in inaccurate pH reuslts | accessdata.fda.gov |
| April 4, 2008 | 47384 | Not yet classified | Terminated | In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qu | False negative hCG results due to decreased sensitivity | accessdata.fda.gov |
| October 17, 2007 | 47352 | Not yet classified | Terminated | Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 | False positive hCG results | accessdata.fda.gov |
| September 26, 2003 | 27414 | Not yet classified | Terminated | Bayer Rapidpoint 405 Blood Gas Analyzer | Potential for bias shift in pO2 values due to air bubble in sample path | accessdata.fda.gov |
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- All makers of Test, Natriuretic Peptide
- All makers of Calibrator, Secondary
- All makers of Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Updated April 29, 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.