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 |
6K95-41 |
Alinity C Iron Reagent Kit |
30227Y600 |
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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