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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.
October 21, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein
Hazard: 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 glycemia may occur and contribute to hypoglycemia.
October 21, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated prot
Hazard: 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 glycemia may occur and contribute to hypoglycemia.
October 14, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitativ
Hazard: Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
September 23, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anti
Hazard: 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.
September 9, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitativ
Hazard: Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
August 12, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Ana
Hazard: If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.
July 8, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics Inc. recalls Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended f
Hazard: Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
July 8, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics Inc. recalls Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for p
Hazard: Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
July 8, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager softw
Hazard: 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
July 8, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Da
Hazard: 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
July 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics Inc recalls RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Hazard: The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
July 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Chemistry Calibrator
Hazard: 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.
July 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Calibrator
Hazard: 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.
July 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Hazard: 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 Atellica IM1600 analyzers.
July 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Hazard: 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.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use i
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantita
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
June 17, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage
Hazard: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
May 6, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Hazard: 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 reagent pack is not calibrated.
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an
Hazard: The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubi
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN:
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Produ
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
April 1, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Prod
Hazard: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
March 25, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 t
Hazard: 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 hormone receptor positive advanced or metastatic breast cancer.