# FDA recall Z-0740-2023

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2022-11-22.

## Product

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

## Reason for recall

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0740-2023
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-22
- **Report date:** 2022-12-28

- **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-0740-2023

## Citation

> AI Analytics. FDA recall Z-0740-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0740-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*