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Sentinel CH SpA recalls Alinity c Iron Reagent, Reference Number 08P3920
Recalled November 29, 2023 · FDA recall Z-0326-2024 · Sentinel CH SpA
Hazard
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 to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results. · FDA Class II
Units
4400 kits
Sold at
Worldwide - US Nationwide distribution.
Description
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 to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
Product
Alinity c Iron Reagent, Reference Number 08P3920
Manufacturer(s)
Sentinel CH SpA
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →