Z-0407-2024 Class II Ongoing
FDA device recall Z-0407-2024 was initiated by Abbott Molecular, Inc. on October 30, 2023 and is designated Class II. Reason for recall: Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. The recall status is ongoing. Affected quantity: 1,881 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 6, 2023
- Initiation Date
- October 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,881 units
Product Description
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
Reason for Recall
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Distribution Pattern
Worldwide
Code Information
a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447