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Siemens Healthcare Diagnostics Recalls
692 recalls on record · July 4, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 16, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Hazard: 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.
May 16, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and
Hazard: 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.
May 16, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanin
Hazard: 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.
May 16, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in
Hazard: 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.
May 9, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Hazard: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
May 9, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Hazard: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
May 9, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
Hazard: When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
May 9, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in v
Hazard: May produce erroneously low results from specific well sets.
May 2, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/
Hazard: Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
April 4, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration
Hazard: An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
March 7, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics recalls BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 471
Hazard: 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).
March 7, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine
Hazard: Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
February 14, 2018Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 1069775
Hazard: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
December 6, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Hazard: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
December 6, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Hazard: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
December 6, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
Hazard: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
December 6, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Produc
Hazard: Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Prolactin (PRL) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Ferritin (FERR) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Estradiol (E2) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 28, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Troponin 1 (TNI) Flex reagent cartridge
Hazard: The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
June 7, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the q
Hazard: 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 2-8¿C, 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 recommended.
May 24, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the qu
Hazard: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.
May 24, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
Hazard: Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.
May 17, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment.
Hazard: Potential Patient Demographic Error with Blank Patient ID Field
April 12, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The A
Hazard: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
April 12, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA C
Hazard: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
April 12, 2017Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Ce
Hazard: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems