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FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

 
• By Elizabeth Orr

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

The word ERROR and binary code on a digital screen.
• Source: Alamy

Abbott Molecular Inc.’s ongoing recall of some COVID-19 lab tests that may display false-positive results is related to a software issue and doesn’t involve any flaws in the physical test components, the US Food and Drug Administration has clarified.

The agency initially announced the recall of the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kits in September, then released its designation as high-risk class I on 14 October. But the following day the FDA updated the recall information to further explain the problems behind the recall

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