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Lower risk Medical device recall · FDA · Published January 29, 2021

Confirm Biosciences Recalls Healgen COVID-19 Test Cassette for In-Home Use Safety

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1125-2021Medical deviceConfirm Biosciences ›
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Contact the company

Recalling firmConfirm Biosciences Inc10123 Carroll Canyon Rd · San Diego, CA 92131-1109
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/63333-confirm-biosciences-recalls-healgen-covid-19-test-cassette-for-in.

Source Summary by GovInfoNow · govinfonow.com/recall/63333-confirm-biosciences-recalls-healgen-covid-19-test-cassette-for-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1125-2021

Cite this page

“Confirm Biosciences Recalls Healgen COVID-19 Test Cassette for In-Home Use Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63333-confirm-biosciences-recalls-healgen-covid-19-test-cassette-for-in. Based on FDA recall #Z-1125-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1125-2021%22&limit=1).

The FDA announced on Jan. 29, 2021, that Confirm Biosciences Inc voluntarily recalled its Healgen COVID-19 IgG/IgM Rapid Test Cassettes due to distribution outside Emergency Use Authorization and inadequate validation for intended use. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Confirm Biosciences
  • Product: Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  • REF: GCC)V-402a
  • Catalog Number: HE Cassette COVID 19EUA
  • Lot Numbers: 2006167eua, 2006168eua, 2006169eua
  • Units affected: 563,840 cassettes

The hazard

The recall addresses two issues: the distribution of test cassettes to non-certified Clinical Laboratories outside of Emergency Use Authorization and the lack of adequate validation for fingerstick tests intended for in-home use. The FDA said these defects compromise the device's reliability for its specific purposes.

Context

GovInfoNow's records show other recent recalls include GET TESTED Continuous Glucose Monitors (2025-11-03), Vivoo Test Strips (2025-11-22), and GET TESTED H. pylori Test (2025-11-03).

How to tell if you have this one

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.

  • Brand
    Confirm Biosciences
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina, Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.
Recall numberProduct, codes & lotsQuantity
Z-1125-2021Healgen 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 anticoagulated blood or serum.; Catalog Number: HE Cassette COVID 19EUA Lot Numbers: 2006167eua 2006168eua 2006169eua563,840 cassettes
Z-1126-2021Orient 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 from anticoagulated blood or serum.; Catalog Number: HE Cassette COVID 19 Lot Numbers: 2002198, 2003244, 2003285, 2003290, 2003291, 2003295, 2003308, 2004148, 2004158, 2005153, 2005154, 2005155, 20052132,003,053 cassettes
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for lot numbers 2006167eua, 2006168eua, or 2006169eua on the cassette packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Jan 29, 202112. FDA classified it Class II: Feb 16, 202123. Published in FDA’s Enforcement Report: Feb 24, 202134. FDA terminated the recall: Dec 13, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1125-2021 (January 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1125-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.