# FDA recall Z-0004-2022

> **Abbott Molecular, Inc.** · Class I · device recall initiated 2021-09-02.

## Product

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File.  in vitro diagnostic

## Reason for recall

There is a potential for false positive results.

## Distribution

Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.

## Key facts

- **Recall number:** Z-0004-2022
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-02
- **Report date:** 2021-10-20
- **Termination date:** 2024-07-23

- **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-0004-2022

## Citation

> AI Analytics. FDA recall Z-0004-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0004-2022. Source: US FDA. Licensed CC0.

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