FDA-Device2025-06-11Class II
Access Testosterone assay, Catalog Number 33560
Beckman Coulter, Inc.
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.
Sold states
US State: FL. UAE, Vietnam
Affected count
70 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
Access Testosterone assay, Catalog Number 33560
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2025Don't want to check this manually?
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