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Alinity i total psa reagent kit
Official notice
5 Jun 2025
Last checked
5 Jun 2025
An official Health Canada notice concerns Alinity i total psa reagent kit. 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 Published 2025-06-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77561
Official notice
2025-06-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Lots
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Abbott Ireland Diagnostics Division, Alinity I Total Psa Reagent Kit.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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