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The alert relates to the Alinity m SARS-CoV-2 AMP Kit and the Alinity m Resp-4-Plex AMP Kit.
The FDA says that the false positives may result from current mixing parameters of the PCR reaction mixture that may result in potential overflow that could carry over into neighboring wells in the assay reagent tray.
Overflow into the wells of true negative samples positioned near positive samples in the assay tray could produce false-positive results.
The agency suggests that providers consider any positive tests from these kits to be presumptive and retest with another type.
Abbott told Benzinga in an emailed statement that 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. The company is also updating the Resp-4-plex EUA assay, which will be completed in next two weeks (in the U.S.).
Price Action: ABT shares are down 0.35% at $126.99 during the market session on the last check Friday.
Editor's Note: The story has been updated with additional emailed statement from Abbott
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