# FDA recall Z-0463-2022

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2021-12-06.

## Product

Alinity m System, Part No. 08N53-002

## Reason for recall

There is an issue with the installation of updated camera firmware on the system.

## Distribution

Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI  OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, and Vietnam

## Key facts

- **Recall number:** Z-0463-2022
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-01-12
- **Termination date:** 2024-09-30

- **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-0463-2022

## Citation

> AI Analytics. FDA recall Z-0463-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0463-2022. Source: US FDA. Licensed CC0.

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