---
title: "Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The... — FDA record Z-0407-2024 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-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/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reve... — FDA record Z-0407-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **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.
- **Classification**: Class II
- **Recalling firm**: Abbott Molecular, Inc.
- **Quantity**: 1,881 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0407-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0407-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 6, 2023
- **Recall initiation date**: Oct 30, 2023
- **Center classification date**: Nov 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0407-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abbott Molecular, Inc. records](https://isitonrecall.com/brand/abbott-molecular-inc/)