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.
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 Quantity: 70 units Lot/code info: UDI-DI: 15099590231347; Serial Number: 538081
15099590231347
Official record: FDA (Device enforcement) ↗
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