Abbott Molecular, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0407-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 30, 2023

Date Posted: December 6, 2023

Recall Number: Z-0407-2024

Event ID: 93230

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.

Status: Ongoing

Product Quantity: 1,881 units

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

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated