Class 2 Device Recall Abbott Alinity

• Date Initiated by Firm: October 30, 2023
• Date Posted: November 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0407-2024
• Recall Event ID: 93230
• PMA Number: P190025
• Product Classification: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus - Product Code MZP
• Product: 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.
• 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
• Recalling Firm/ Manufacturer: Abbott Molecular, Inc.; 1300 E Touhy Ave; Des Plaines IL 60018-3315
• For Additional Information Contact: Ray Bastian; 224-361-7000
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 1,881 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MZP