# FDA recall Z-1665-2025

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2025-03-20.

## Product

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

## Reason for recall

The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1665-2025
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-20
- **Report date:** 2025-04-30

- **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-1665-2025

## Citation

> AI Analytics. FDA recall Z-1665-2025. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1665-2025. Source: US FDA. Licensed CC0.

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