Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access SARS-CoV-2 Antigen Calibrators Recalled by Beckman Coulter Inc. Due to SARS-CoV-2 Antigen Assay test may generate false positive...
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 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Quantity: 451 units
Why Was This Recalled?
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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