# FDA recall Z-1748-2025

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2025-04-28.

## Product

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

## Reason for recall

There were reports of an increase in reactive negative controls and false positive results.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1748-2025
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-28
- **Report date:** 2025-05-21

- **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-1748-2025

## Citation

> AI Analytics. FDA recall Z-1748-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1748-2025. Source: US FDA. Licensed CC0.

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