# FDA recall Z-1349-2023

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

## Product

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

## Reason for recall

The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit.  After correction of the issue, the instrument was returned for use without calibration.  This would result in a potential for delay of results and incorrect results.

## Distribution

US Distribution to state of:  PA, a government account.

## Key facts

- **Recall number:** Z-1349-2023
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-11
- **Report date:** 2023-04-12

- **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-1349-2023

## Citation

> AI Analytics. FDA recall Z-1349-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1349-2023. Source: US FDA. Licensed CC0.

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