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.
This recall is currently active, issued November 29, 2023. It was issued by Abbott Molecular, Inc..
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- October 30, 2023
- Posted
- November 29, 2023
- Recall Number
- Z-0407-2024
- Quantity
- 1,881 units
- Firm Location
- Des Plaines, IL
- Official Source
- View on FDA website ↗
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
Worldwide
Lot / Code Info
a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447
Root Cause
Other
Action Taken
Abbott issued an Urgent Field Safety Notice to its consignees on 10/30/2023 via letter delivered using FedEx priority overnight express. The notice explained the problem, the potential impact/risk to patient, and requested the following actions: -discard all affected product -notify all those to which the products were transferred -follow internal laboratory procedures in the case of suspected incorrect results Credit or replacement will be issued for units discarded/destroyed. Abbott expanded the recall and notified consignees on 07/23/2024 via letter. The letter instructed consignees of an additional lot number included in the recall, but otherwise contained the same instructions.