Official recall record
Alinity I Total PSA Reagent Kit
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-06-05
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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