Class II
Medical Device Recall: Access Testosterone assay, Catalog Number 33560
Beckman Coulter, Inc. · May 5, 2025
Reason for Recall
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Distribution
US State: FL. UAE, Vietnam
States Affected
FL
Quantity Affected
70 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1901-2025
Status: ongoing
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