Z-0326-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4400 kits
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
UDI-DI: 00380740136253; Lot Number: 21046Y600, 21118Y600, 30227Y600, 30302Y600