FDA (Devices) recall action 88626
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
There is a potential for false positive results.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Abbott Molecular is recalling the Alinity m Resp-4-Plex AMP Kit due to potential false positive results. The recall affects 5,855 units distributed worldwide.
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.