Two COVID-19 lab test kits made by Abbott Molecular could show false positive results, the FDA said Sept. 20.
The agency said providers should consider retesting positive patient specimens from either of the two tests (Alinity m SARS-CoV-2 AMP kit, list number 09N78-095, and Alinity m Resp-4-Plex AMP kit, list number 09N79-096) performed in the last two weeks with a different authorized test. The agency also said providers should consider informing patients with positive results since June that their results may have been erroneous.
In an email statement, Abbott said it is "implementing an update to its Alinity m SARS-CoV-2 EUA assay. The update to the SARS-CoV-2 EUA assay is nearly complete. We are also updating our Resp-4-plex EUA assay, which will be completed in next two weeks (in the U.S.)."