Z-0407-2024Class II

Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in...

Name: Z-0407-2024 Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in...
Creator: Abbott Molecular, Inc.
Published: 2023-10-30
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2023-10-30 / Open, Classified

FDA source

Abbott Molecular, Inc. began a recall of 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... on 2023-10-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0407-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-30
Posted: 2023-11-29
Recalling firm: Abbott Molecular, Inc.
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.
Product code: MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
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 root 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
Product codes and lots: a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29

Product code MZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)