Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a Recalled by Confirm Biosciences Inc Due to Due to two (2) issues: 1) The firm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Confirm Biosciences Inc directly.
Affected Products
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 anticoagulated blood or serum.
Quantity: 563,840 cassettes
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Confirm Biosciences Inc
Confirm Biosciences Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report