FDA Devices Critical Class I Terminated

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

Reported: October 20, 2021 Initiated: September 2, 2021 #Z-0004-2022

Product Description

Reason for Recall

There is a potential for false positive results.

Details

Recalling Firm: Abbott Molecular, Inc.
Units Affected: 60563 units
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.
Location: Des Plaines, IL

Frequently Asked Questions

What product was recalled? ▼

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic. Recalled by Abbott Molecular, Inc.. Units affected: 60563 units.

Why was this product recalled? ▼

There is a potential for false positive results.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 20, 2021. Severity: Critical. Recall number: Z-0004-2022.