Product Wiki · Recalls · Health Canada — Medical Devices

Alinity and Architect A1C Reagent Kit — recall 64283

Health Canada — Medical Devices · Canada · 2022-06-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
64283
Date of alert
2022-06-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values. to address this issue, a revision to the total hemoglobin low linearity value for the architect hemoglobin a1c whole blood and hemolysate applications has been implemented. Recall start date: June 15, 2022
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-and-architect-a1c-reag

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