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Recall Observatory FDA recall evidence

Device 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.

Z-0407-2024

October 30, 2023

Class II

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 93230
Status
Ongoing
Classification
Class II
Quantity
1,881 units
Official record key
device-enforcement:Z-0407-2024

Official wording

Reason: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.