The Recall Desk

FDA (Devices) recall action 87263

Confirm Biosciences Inc recalled 2 products on 2021-02-24

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
2021-02-24
Critical
0
Units
2,566,893

Why these products were recalled

Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).

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)··2021-02-24

    Confirm Biosciences Recalls Orient Gene COVID-19 Rapid Test Cassettes

    Confirm Biosciences is recalling Orient Gene COVID-19 Rapid Test Cassettes because they were distributed outside Emergency Use Authorization and not validated for fingerstick use.

    Product
    Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma fro
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2021-02-24

    Confirm Biosciences Recalls Healgen COVID-19 Rapid Test Cassettes

    Confirm Biosciences is recalling Healgen COVID-19 Rapid Test Cassettes because they were distributed to non-certified labs and not validated for fingerstick use.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from antic
    Category
    Distribution
    49 states