Access Testosterone assay, Catalog Number 33560
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.
US State: FL. UAE, Vietnam
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2025