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Beckman Coulter, Inc. recalls Access 2 Immunoassay Analyzer, Catalog Number 81600N
Recalled March 26, 2025 · FDA recall Z-1386-2025 · Beckman Coulter
Hazard
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results. · FDA Class II
Units
873 units
Sold at
Worldwide - US Nationwide distribution.
Description
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
Product
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →