FDA adds Class I recall label to Abbott Alinity COVID tests after risk of false positives

A month after Abbott issued a safety notice describing a defect that could cause some of its COVID-19 tests to return false positive results, the FDA has upgraded the issue into a Class I recall.

In early September, Abbott notified its healthcare provider and laboratory customers that it had identified an issue with the software used by special lab processing equipment to prepare swab samples for testing with its Alinity m SARS-CoV-2 and Alinity m Resp-4-Plex assays.