Alinity I Total PSA Reagent Kit
Brand(s)
Last updated
Summary
Product
Alinity I Total PSA Reagent Kit
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Alinity I Total PSA Reagent Kit | 73162FZ00 71210FZ00 71210FZ01 71343FZ00 73298FZ00 73155FZ00 71213FZ00 73155FZ01 71346FZ00 73728FZ00 | 07P9220 07P9230 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Immunology
Companies
Abbott Ireland, Diagnostics Division
Finisklin Business Park, Sligo, Ireland
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77561
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