Alinity I Total PSA Reagent Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Alinity I Total PSA Reagent Kit |
73162FZ00 |
07P9220 |
Issue
An elevated number of complaints have been reported involving both out-of-range third-party quality control (qc) results and a positive bias in patient sample results when using specific product lots. Internal testing with patient samples, including retained lot analysis and trending of patient result medians, confirmed that some lots may exhibit a greater than 10% positive bias.
Recall start date: May 22, 2025
Additional information
Details
Abbott Ireland, Diagnostics Division
Finisklin Business Park, Sligo, Ireland
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