The Recall Desk

Hazard

Biotin Interference recalls

28 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
28
Critical
0
Severe
0
Most recent
2020-06-10

Of the 28 biotin interference recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all biotin interference recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 28

  • HighFDA (Devices)·Z-2242-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Antibody II Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin Antibody II assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel D
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2237-2020·2020-06-10

    Beckman Coulter Access Free T4 Thyroxine Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T4 Thyroxine assays because biotin can cause significant result bias, potentially affecting patient care.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and Uni
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2238-2020·2020-06-10

    Beckman Coulter Free T3 Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2241-2020·2020-06-10

    Beckman Coulter Access GI Monitor Cancer Antigen 19-9 Recalled for Biotin Interference

    Beckman Coulter is recalling Access GI Monitor Cancer Antigen 19-9 assays because biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i,
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2240-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and Un
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-2239-2020·2020-06-10

    Beckman Coulter Access Total T3 Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Total T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel D
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0059-2019·2018-10-10

    Ortho VITROS FSH Reagent Pack Recalled for Potential Biased Results

    Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.

    Product
    VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0058-2019·2018-10-10

    Ortho VITROS Folate Reagent Pack Recall for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.

    Product
    VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2019·2018-10-10

    Ortho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
    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-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-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-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-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-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-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-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-1690-2018·2018-05-16

    Siemens ADVIA Centaur HBc IgM Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.

    Product
    ADVIA Centaur¿ HBc IgM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1671-2018·2018-05-16

    Siemens Cardiac Troponin I Reagent Cartridge Recalled for Biotin Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Cardiac Troponin I reagent cartridges because they are susceptible to interference from biotin, which is not listed in the instructions for use.

    Product
    Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1677-2018·2018-05-16

    Siemens IMMULITE Assay Recalled Due to Biotin Interference Risk

    Siemens Healthcare Diagnostics is recalling specific IMMULITE assays because biotin can interfere with results, potentially affecting patient care.

    Product
    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2638-2017·2017-07-05

    Beckman Coulter Access System-GI Monitor Recalled for Biotin Interference

    Beckman Coulter is recalling Access System-GI Monitor (CA19-9) kits because they are susceptible to biotin interference, which may affect test results.

    Product
    Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
    Category
    Medical Device
    Distribution
    3 states