Recall Monitor
Health Products

Alinity I Total PSA Reagent Kit

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Immunology
Product: Alinity I Total PSA Reagent Kit
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Alinity I Total PSA Reagent Kit73162FZ00
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

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