The Recall Desk

FDA (Devices) recall action 88874

Bio-Rad Laboratories, Inc. recalled 2 products on 2021-11-24

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-11-24
Critical
0
Units
12,401

Why these products were recalled

Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.

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

1–2 of 2

  • HighFDA (Devices)··2021-11-24

    Syphilis Test Reagent Pack Recalled Due to False Positive Results

    Bio-Rad is recalling 11,610 units of BioPlex 2200 syphilis test reagent packs because they can produce false positive results that don't confirm with follow-up tests, due to elevated reactivity and shelf-life issues.

    Product
    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or ti
    Category
    Distribution
    41 states
  • HighFDA (Devices)··2021-11-24

    Syphilis Test Calibrator Recalled for False-Positive Reactivity Issues

    Bio-Rad BioPlex 2200 Syphilis calibrator set (791 units, Lot 52953) is recalled due to elevated test reactivity that does not confirm with treponemal tests and potential early shelf-life failure causing measurement bias.

    Product
    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
    Category
    Distribution
    41 states