Confirm Biosciences recalls Orient Gene COVID-19 IgG/IgM Rapid Test Cassette (REF GCCOV-402a) due to distribution outside emergency use authorization and inadequate validation for in-home fingerstick tests. Affected lot numbers listed.
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 has recalled Orient Gene's COVID-19 IgG/IgM Rapid Test Cassette (REF GCCOV-402a) because it was distributed to non-certified labs and isn't properly validated for home use. This could lead to inaccurate test results if used incorrectly.
The test cassette was distributed outside emergency use authorization to non-certified labs and wasn't validated for home use. This means it might not give accurate results when used by people at home, leading to incorrect health decisions.
People who purchased the affected lot numbers of the Orient Gene COVID-19 Rapid Test Cassette for home use are most at risk. The product was intended for in-home fingerstick testing but may not work correctly.
Check for lot numbers: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, 2005213. The product is labeled as Orient Gene COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
Look for the lot numbers listed: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, 2005213.
The test was distributed outside emergency use authorization to non-certified labs and wasn't validated for home use, which could lead to inaccurate results.
The product was intended for home use but may not work correctly due to inadequate validation, so it's not recommended for accurate testing.
Check the lot number against the list provided. If it matches, stop using it and contact Confirm Biosciences for guidance.
We’ve drafted a message you can send Confirm Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1126-2021 — Confirm Biosciences Confirm Biosciences Hello, I own a Confirm Biosciences that is covered by recall Z-1126-2021 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.
