Z-0325-2024 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
- 4394 kits
Product Description
IRON assay, Reference Numbers 6K95-41 and 6K95-30
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
Reference Number 6K95-41: UDI-DI: 00380740010928; Lot Number: 30610Y600; Reference Number 6K95-30: UDI-DI: 00380740010911; Lot Numbers: 21058Y600, 21101Y600, 30918Y600