The Recall Desk

Manufacturer

Confirm Biosciences Inc

2 recalls in our database name Confirm Biosciences Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-02-24

Of the 2 recalls from Confirm Biosciences Inc 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 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.

1–2 of 2

  • HighFDA (Devices)·Z-1126-2021·2021-02-24

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2021·2021-02-24

    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
    Medical Device
    Distribution
    Distributed nationwide