Confirm Biosciences recalls Healgen COVID-19 IgG/IgM Rapid Test Cassette (REF GCC)V-402a due to distribution outside Emergency Use Authorization and inadequate validation for fingerstick home testing. Affected units include specific lot numbers.
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).
Confirm Biosciences is recalling Healgen COVID-19 IgG/IgM Rapid Test Cassettes (REF GCC)V-402a because they were distributed to non-certified labs and not properly validated for home fingerstick use. This could lead to inaccurate results if used by consumers at home.
The test cassettes were distributed outside of Emergency Use Authorization to non-certified labs and were not validated for home fingerstick testing. This means the results might be inaccurate when used by consumers at home, potentially leading to incorrect health decisions.
People who purchased the Healgen COVID-19 IgG/IgM Rapid Test Cassette (REF GCC)V-402a with lot numbers 2006167eua, 2006168eua, or 2006169eua for home use are affected. Those using the test for fingerstick blood samples may get inaccurate results.
Check the lot number on the cassette: 2006167eua, 2006168eua, or 2006169eua. The product is a lateral flow immunoassay for detecting SARS-CoV-2 antibodies in whole blood, serum, or plasma.
Look for lot numbers 2006167eua, 2006168eua, or 2006169eua on the cassette packaging.
The test cassettes were distributed outside Emergency Use Authorization to non-certified labs and were not validated for home fingerstick use, which could lead to inaccurate results.
Check the lot number on the cassette. If it matches 2006167eua, 2006168eua, or 2006169eua, stop using it and contact Confirm Biosciences for instructions.
No, the test was not validated for home fingerstick use, so results may be inaccurate. Do not use it for home testing.
We’ve drafted a message you can send Confirm Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1125-2021 — Confirm Biosciences Confirm Biosciences Hello, I own a Confirm Biosciences that is covered by recall Z-1125-2021 from Confirm Biosciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
