Recall Z-0326-2024— Sentinel CH SpA
Class II · Ongoing
Class II FDA medical device recall by Sentinel CH SpA, initiated 2023-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Alinity c Iron Reagent, Reference Number 08P3920. Reason: 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..
- Recalling firm
- Sentinel CH SpA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-29
- Firm location
- Milan, N/A, Italy
Product description
Alinity c Iron Reagent, Reference Number 08P3920
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.