Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
- Recall date
- May 5, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1901-2025
- FDA classification
- Class II
- Brand / firm
- Beckman Coulter, Inc.
- Sold / distributed
- US State: FL. UAE, Vietnam
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Access Testosterone assay, Catalog Number 33560
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