The U.S. Food and Drug Administration (FDA) has announced the recall of two molecular SARS-CoV-2 tests from Abbott.
The tests are the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kit, which Abbott recalled 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.
The FDA recommends labs consider all positive SARS-CoV-2 test results presumptive until the company can implement updated software specification files to correct the issue at each customer’s laboratory site.