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FDA Classifies Abbott SARS-CoV-2 Molecular Test Recall as Class I Due to False Positives

Story has been updated to indicate that the software is the key issue.

NEW YORK – The US Food and Drug Administration announced on Thursday that it has classified the recall of Abbott's Alinity M SARS-CoV-2 AMP Kits and Alinity M Resp-4-Plex AMP Kits due to the potential for false positives as a Class I recall.

The agency previously alerted users to the issue last month, warning that the false results could be related to current mixing parameters for the chemicals that are combined with patient samples to detect the viruses.

In certain cases, the mixing parameters of the PCR reaction mixture can result in overflow that is carried into neighboring wells in the assay reagent tray. The overflow into wells with negative samples could contaminate the samples and produce false positives, the FDA said in its original notice.

On Monday, the FDA updated information on the recall notice to clarify that the issue is with the software used with the kits. 

The FDA noted in Thursday's Class I recall notice that there have been no deaths or adverse health consequences reported from the use of the tests.

In September, Abbott issued a recall requesting impacted customers to consider positive test results to be presumptive until the company could implement update software specification files to correct the issue at each customer's laboratory site.

The Abbott Park, Illinois-based company is correcting 187 software installations, the FDA said.