Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK Recalled by Beckman Coulter Inc. Due to Firm's submission for Emergency Use Authorization (EUA) contained...
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 Beckman Coulter Inc. directly.
Affected Products
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
Quantity: 303 kits (U.S.) and 964 kits (O.U.S.)
Why Was This Recalled?
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report