Abbott Molecular, Inc.: Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Is my product affected?

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

• UPC 00884999049222
• UPC 00884999050211

Check against the official notice below — it lists the full affected range.

What happened

Abbott Molecular, Inc. is recalling the Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File because there is a potential for false positive results. The recall affects 11,408 units distributed worldwide, including the United States, 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 the U.S. Virgin Islands.

The affected products are identified by specific lot and serial numbers with expiration dates ranging from June 2022 through February 2023. These include List Number 09N78-091 and List Number 09N78-03E with their associated UDI codes and lot numbers. The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential for false positive results.

Details from the source

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 VI Quantity: 11408 units Lot/code info: List Number: 09N78-091, UDI 00884999049222; Lot/Serial, Expiration: 520596, 06/18/2022; 520952, 07/09/2022; 524054, 10/18/2022; 524965, 10/25/2022; 525462, 12/10/2022; 525768, 12/16/2022; 526708, 01/18/2023; 527842, 02/08/2023; List Number 09N78-03E, UDI (01)00884999050211(240)09N78-03E(8012)5.oo

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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