FDA clarifies recall of products from Abbott

Oct. 20, 2021

The U.S. Food and Drug Administration (FDA) updated information about a recall announced last week on Abbott’s Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP kit. The FDA clarified that the recall is limited to the software associated with the products.

Once Abbott implements updated software specification files to correct the issue at customers’ sites, those labs can continue to use the test kits.

The recall was issued because of the potential for false positive results.

The false positive results may be related to the current mixing parameters for the chemicals that are combined with patient samples to detect the viruses, the FDA said. In some cases, the mixing parameters may cause a sample in one well of the machine’s tray to overflow into another sample well. Overflow into the wells of true negative samples that are positioned near positive samples in the tray could produce false positive results, the FDA added.

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