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Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
Recalled June 11, 2025 · FDA recall Z-1901-2025 · Beckman Coulter
Hazard
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. · FDA Class II
Units
70 units
Sold at
US State: FL. UAE, Vietnam
Description
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.
Product
Access Testosterone assay, Catalog Number 33560
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →