# FDA recall Z-0461-2022

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

## Product

Alinity m System, Part No. 08N53-002

## Reason for recall

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-0461-2022
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-06
- **Report date:** 2022-01-12

- **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-0461-2022

## Citation

> AI Analytics. FDA recall Z-0461-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0461-2022. Source: US FDA. Licensed CC0.

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