Medical Device Recall: Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc. · February 5, 2025
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
873 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1386-2025
Status: ongoing
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