Reported Feb 24, 2021 · Terminated
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral…
Confirm Biosciences Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Confirm Biosciences Inc · 10123 Carroll Canyon Rd · San Diego, CA · 92131-1109
Is this the product you have?
- Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
- REF GCC)V-402a - Product Usageis 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
- Lot codes and dates
- Catalog NumberHE
- Cassette COVID 19EUA Lot Numbers2006167eua 2006168eua 2006169eua
- Amount recalled
- 563,840 cassettes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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