Alinity C Iron Reagent Kit
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Iron | 30918Y600 30610Y600 21101Y600 21058Y600 | 6K95-41 6K95-30 |
| Alinity C Iron Reagent Kit | 30227Y600 21118Y600 30302Y600 21046Y600 | 08P3920 |
Issue
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
Additional information
Details
| Sentinel Ch. Spa |
| Via Robert Koch, 2, Milan, Italy, 20152 |
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