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

FDA device recall Z-0407-2024 · posted 2023-11-29 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

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.

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.

Root cause

Other

Status

Open, Classified

Product code

MZP

Quantity affected

1,881 units

Distribution

Worldwide

Date initiated

2023-10-30

Date posted

2023-11-29

Location

Des Plaines, IL