The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

601–625 of 667

  • HighFDA (Devices)·Z-2127-2013·2013-09-18

    Siemens MicroscanrapID/S panels recalled for antimicrobial misreads

    Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 2 Recall

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 2 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2121-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Panels Recalled for Misreads

    Siemens is recalling Microscan Synergies Plus Negative panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2013·2013-09-04

    Siemens Dimension Vista Systems Recalled for Potential Sample Dispensing Error

    Siemens is recalling Dimension Vista 500 and 1500 systems due to a rare software issue that may cause samples to be dispensed into previously used wells.

    Product
    Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to dete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1970-2013·2013-08-21

    Siemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator A lots due to under-recovery in the Total T4 assay, which may affect calibration accuracy.

    Product
    ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1886-2013·2013-08-14

    Siemens IMMULITE Rapid TSH Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Rapid TSH tests because they fail to detect a rare TSH variant identified in a small patient cluster.

    Product
    IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2013·2013-08-14

    Siemens IMMULITE TSH Assay Recalled for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE Systems Third Generation TSH assays because a rare TSH variant is not detected.

    Product
    IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2013·2013-08-14

    Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.

    Product
    Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2013·2013-08-14

    Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.

    Product
    ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2013·2013-08-14

    Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection

    Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.

    Product
    Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2013·2013-08-14

    Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues

    Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.

    Product
    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2013·2013-08-14

    Siemens TSH Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension Vista System TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2013·2013-08-14

    Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2013·2013-06-19

    Siemens MicroScan Dried Negative Breakpoint Combo 47 Panels Recalled

    Siemens Healthcare Diagnostics is recalling MicroScan Dried Negative Breakpoint Combo 47 panels due to potential false negative or delayed Arginine results.

    Product
    Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1513-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Assay Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1514-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1515-2013·2013-06-12

    Siemens ADVIA Centaur iPTH Calibrator Recalled for Variability

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.

    Product
    ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibrating Intact PTH assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2013·2013-05-15

    Siemens MicroScan MICroSTREP panels recalled for false susceptibility results

    Siemens is recalling MicroScan MICroSTREP plus Type 1 panels because they may produce false antimicrobial susceptibility results for Streptococcus agalactiae.

    Product
    Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1151-2013·2013-04-24

    Siemens Vista Drug 4 Calibrator Recalled for Low Bias

    Siemens is recalling Vista Drug 4 Calibrators because they cause low digoxin test results, potentially affecting patient care.

    Product
    Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-1119-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1121-2013·2013-04-24

    Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.

    Product
    ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2013·2013-04-17

    Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity

    Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.

    Product
    Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
    Category
    Medical Device
    Distribution
    Distributed nationwide