FDA recall Z-0004-2022

Abbott Molecular, Inc. · Class I · device

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2022