# FDA recall Z-0407-2024

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2023-10-30.

## 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 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.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0407-2024
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-30
- **Report date:** 2023-12-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Des Plaines, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2024

## Citation

> AI Analytics. FDA recall Z-0407-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0407-2024. Source: US FDA. Licensed CC0.

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