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.

301–325 of 667

  • 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-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-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-1685-2018·2018-05-16

    Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assay kits because the user instructions fail to list the biotin concentration levels that cause test interference. This omission may lead to inaccurate diagnostic results for patients taking biotin supplements.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2018·2018-05-16

    Siemens ADVIA Salicylate Reagent Recalled for Potential Test Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Salicylate reagent chemistry assays because various blood, urine, or cerebrospinal fluid assays may interfere with sulfasalazine and sulfapyridine, causing falsely elevated or depressed salicylate results.

    Product
    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
    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
  • 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-1656-2018·2018-05-16

    Siemens Dimension Vista ALTI Assay Recalled for Drug Interference

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

    Product
    Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • 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-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-1657-2018·2018-05-16

    Siemens Dimension Vista AST Assay Recalled for Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista AST assays because they may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.

    Product
    Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
    Category
    Medical Device
    Distribution
    3 states
  • 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-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-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-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-1691-2018·2018-05-16

    Siemens IMMULITE 2000 BR-MA (CA15-3) Assay Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 BR-MA (CA15-3) assays because biotin interference is not listed in the instructions for use.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-1681-2018·2018-05-16

    Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

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

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2018·2018-05-16

    Siemens IMMULITE Gastrin Assay Recalled for Biotin Interference

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

    Product
    IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1675-2018·2018-05-16

    Siemens IMMULITE Assays Recalled for Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin interference is not documented in the instructions, potentially affecting test accuracy.

    Product
    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (Pa
    Category
    Medical Device
    Distribution
    3 states