Alinity I Total Psa Reagent Kit

Alinity I Total PSA Reagent Kit Recall Abbott is recalling the Alinity I Total PSA Reagent Kit across Canada due to a performance issue with the product. This reagent kit is used in laboratory testing to measure PSA (prostate-specific antigen) levels. The recall affects all Canadian healthcare facilities and laboratories that use this testing kit.

Product
Alinity I Total PSA Reagent Kit
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-06-05
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b90c0d46-8a84-4ce5-9b7a-47db28003aec