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
RecallTracker