medical Class II Updated 2025-02-12

Beckman Coulter Inc. recalls Access PCT Reagent Pack, Catalog Number C53987, when used on

Recalled Product

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI 15099590736002 Lots 339062, 439811
View official government recall

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