The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

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

What the numbers show

Total
668
Critical
5
Severe
19
Most recent
2026-10-07

Of the 668 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 19 (3%) 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.

301–325 of 668

  • HighFDA (Devices)·Z-1679-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2018·2018-05-16

    Siemens Dimension Vista Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1662-2018·2018-05-16

    Siemens Syva Emit 2000 Sirolimus Assay Recalled for Interference

    Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1650-2018·2018-05-16

    Siemens Dimension ALTI Assay Recalled for Drug Interference

    Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.

    Product
    Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1683-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.

    Product
    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2018·2018-05-16

    Siemens Dimension Glucose Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1670-2018·2018-05-16

    Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.

    Product
    Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1669-2018·2018-05-16

    Siemens Dimension Free Thyroxine Reagent Cartridge Recall for Labeling Error

    Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.

    Product
    Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2018·2018-05-16

    Siemens Dimension Vista Glucose Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1668-2018·2018-05-16

    Siemens Recalls Dimension TSHL Reagent Cartridges Due to Biotin Labeling Error

    Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.

    Product
    Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2018·2018-05-16

    Siemens ADVIA Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.

    Product
    ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1654-2018·2018-05-16

    Siemens Dimension Thyroxine Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Thyroxine assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1689-2018·2018-05-16

    Siemens ADVIA Centaur Folate Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.

    Product
    ADVIA Centaur¿ Folate (FOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2018·2018-05-16

    Siemens IMMULITE 2000 Folic Acid Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Folic Acid assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1653-2018·2018-05-16

    Siemens Creatine Kinase MB Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.

    Product
    Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1678-2018·2018-05-16

    Siemens IMMULITE CEA Assay Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling IMMULITE CEA assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 CEA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1649-2018·2018-05-16

    Siemens Dimension Ammonia Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1674-2018·2018-05-16

    Siemens IMMULITE 2000 Allergy IgE Kit Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Allergy specific IgE Universal Kits because biotin interference is not documented in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2018·2018-05-16

    Siemens Creatine Kinase MB Assay Recalled for Drug Interference

    Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.

    Product
    Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1651-2018·2018-05-16

    Siemens Dimension AST Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.

    Product
    Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1686-2018·2018-05-16

    Siemens IMMULITE Vitamin B12 Assay Recalled Due to Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1682-2018·2018-05-16

    Siemens IMMULITE CA125 Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE CA125 assays because biotin interference thresholds are not listed in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1647-2018·2018-05-16

    Siemens ALT Assay Reagents Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling ADVIA ALT reagent chemistry assays because they may produce inaccurate results when used with certain drugs.

    Product
    ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1673-2018·2018-05-16

    Siemens Recalls Dimension Vista TSH Reagent Cartridges for Labeling Error

    Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.

    Product
    Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1660-2018·2018-05-16

    Siemens Dimension Vista Thyroxine Assay Recalled for Drug Interference

    Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.

    Product
    Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states