Product Wiki · Recalls · Health Canada — Medical Devices

Alinity C Iron Reagent Kit — recall 74426

Health Canada — Medical Devices · Canada · 2023-10-16 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74426
Date of alert
2023-10-16
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: Sentinel Ch Spa, the manufacturer of iron for use with Architect and Alinity C Iron Reagent Kit, has identified an issue with the reagents. Some customers have experienced elevated quality control (QC) results as well as elevated patient results. A high recovery of iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of quality control and patient samples results, up to 15% for iron products (Alinity C Iron Reagent ref. 08p3920) to be used on Abbott Alinity instrument and 30% for iron products (iron ref. 6k95-41 and iron ref. 6k95-30) to be used on Abbott Architect instrument. Recall start date: September 29, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/alinity-c-iron-reagent-kit

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