Official recall record
Alinity C Iron Reagent Kit
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-10-16
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Record last checked against the registry on 2026-05-31.