Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access PCT Reagent Pack Recalled by Beckman Coulter Inc. Due to Identified reagent lots are experiencing a high rate...
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 PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Quantity: 6,994 US; 10,067 OUS
Why Was This Recalled?
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
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