The Recall Desk

FDA (Devices) recall action 84862

Beckman Coulter Inc. recalled 6 products on 2020-06-10

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-06-10
Critical
0
Units
2,349,364

Why these products were recalled

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··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
    Distribution
    52 states
  • ModerateFDA (Devices)··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
    Distribution
    52 states
  • ModerateFDA (Devices)··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
    Distribution
    52 states
  • HighFDA (Devices)··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
    Distribution
    52 states
  • ModerateFDA (Devices)··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
    Distribution
    52 states
  • HighFDA (Devices)··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
    Distribution
    52 states