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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.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to qua
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimu
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid s
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormon
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.
August 14, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T).
Hazard: A rare variant of TSH, identified in a small cluster of patients, is not detected.
June 19, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determin
Hazard: The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction.
June 12, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH
Hazard: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
June 12, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
Hazard: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
June 12, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the qu
Hazard: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
June 12, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determin
Hazard: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
May 15, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designe
Hazard: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
April 24, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
Hazard: Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2KD052 or Drug 4 Cal (KC460A) lot 2KD053. Internal testing has shown an average 15% low bias in the therapeutic range of 0.9 to 2.0 ng/mL.
April 24, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vi
Hazard: Negative bias in patient samples for Vitamin D
April 24, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vi
Hazard: Negative bias in patient samples for Vitamin D
April 24, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vi
Hazard: Negative bias in patient samples for Vitamin D
April 24, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of V
Hazard: Negative bias in patient samples for Vitamin D
April 17, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time
Hazard: Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life which is demonstrated by testing with Dade(R) Citrol(R) Heparin Control, low and high.
April 10, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dime
Hazard: Siemens Healthcare Diagnostics has initiated a voluntary field action for Dimension(R) PHOS Flex(R) Reagent due to reagent interaction causing falsely depressed Creatinine results when EZCR is processed from open wells that are in close proximity to open wells of PHOS reagent.
April 10, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in hum
Hazard: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
April 10, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in
Hazard: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
April 10, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in huma
Hazard: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
April 3, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for th
Hazard: Correlation slope bias and accuracy shift
March 27, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic tes
Hazard: Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values
March 20, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantita
Hazard: The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
February 6, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitr
Hazard: Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063. Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended
Hazard: Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme imm
Hazard: Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid st
Hazard: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls Immunoradiometric assay.
Hazard: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
January 16, 2013Medical DevicesFDA
Siemens Healthcare Diagnostics recalls Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid st
Hazard: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)