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.

376–400 of 667

  • ModerateFDA (Devices)·Z-1140-2017·2017-02-15

    Siemens Dimension Ammonia Reagent Cartridges Recalled for Calibration Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially leading to abnormal assay results.

    Product
    Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of seve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2017·2017-02-15

    Siemens Dimension Vista Ammonia Flex Reagent Cartridge Recall

    Siemens is recalling specific lots of Dimension Vista Ammonia Flex reagent cartridges because they may not meet the 60-day calibration interval claim, potentially resulting in abnormal assay results.

    Product
    Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2017·2017-02-08

    Siemens Recalls IMMULITE PSA Kits Due to Negative Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2017·2017-02-08

    Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results

    Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in huma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0979-2017·2017-01-18

    Siemens Recalls Intact PTH Assay Kits Due to Negative Bias

    Siemens is recalling IMMULITE 2000 Intact PTH assay kits because they may show a negative bias of up to -39% at low concentrations.

    Product
    SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2017·2016-12-28

    Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.

    Product
    IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2017·2016-12-28

    Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0652-2017·2016-11-30

    Siemens Dimension Vista Chemistry 1 Calibrator Recall for Low Calcium Recovery

    Siemens is recalling Dimension Vista Chemistry 1 Calibrators (lots 5GM081 and 5GM082) because they may cause discrepant low calcium recovery in quality control and patient samples.

    Product
    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Plasma Sample Bias

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias when testing plasma samples instead of serum.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2017·2016-11-23

    Siemens Recalls Advia Chemistry Calibrator Due to Bilirubin Bias

    Siemens is recalling Advia Chemistry Calibrators because incorrect values may cause a 41% positive bias in Direct Bilirubin patient results.

    Product
    Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CRE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2017·2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2017·2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2017·2016-11-23

    Siemens FlexLab Automation Modules Recalled for Potential Safety Concerns

    Siemens Healthcare Diagnostics is voluntarily recalling 448 FlexLab Automation Modules. The recall was initiated by the firm and is classified as Class II.

    Product
    FlexLab Automation Modules
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Specimen Correlation Issues

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias in plasma samples compared to serum samples.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0401-2017·2016-11-23

    Siemens Recalls Dimension Vista IRON Flex Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling Dimension Vista IRON Flex reagent cartridges due to deferoxamine interference at concentrations not listed in the Instructions for Use.

    Product
    Dimension Vista IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0402-2017·2016-11-23

    Siemens Recalls Dimension IRON Flex Reagent Cartridges Due to Interference

    Siemens Healthcare Diagnostics is recalling Dimension IRON Flex reagent cartridges because deferoxamine interferes with the assay at a different concentration than listed in the instructions.

    Product
    Dimension IRON Flex reagent cartridges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare Diagno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE CMV IgM Assay kits due to reported increases in imprecision and high coefficient of variation (CV) values.

    Product
    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2017·2016-10-19

    Siemens Recalls Rubella IgM Assay Kits Due to False Positive Results

    Siemens is recalling specific lots of Rubella IgM assay kits because they may produce false positive or indeterminate results on certain analyzers.

    Product
    SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2017·2016-10-19

    Siemens Rubella IgM Assay Recalled for False Positive Results

    Siemens is recalling specific lots of Rubella IgM assays due to increased false positive and indeterminate results.

    Product
    SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0039-2017·2016-10-12

    Siemens Dimension Vista Calcium Reagent Cartridge Recall for Erroneous Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium reagent cartridges that may produce inaccurate test results.

    Product
    Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2913-2016·2016-10-12

    Siemens RAPIDPoint 405 Cartridges Recalled for Chloride Calibration Error

    Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.

    Product
    Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
    Category
    Medical Device
    Distribution
    Distributed nationwide