Device product
Alinity c Iron Reagent, Reference Number 08P3920
Z-0326-2024
Product summary
- Firm
- Sentinel CH SpA
- Event
- Event 93298
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4400 kits
- Official record key
device-enforcement:Z-0326-2024
Official wording
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.
Code information: UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
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.