Abbott Molecular Inc. recalls SARS-CoV-2 test kits due to false positives

Abbott Molecular Inc. yesterday issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and Aug. 31, 2021, for their potential to give false positive results. The Food and Drug Administration has identified this as a Class I recall, the most serious type. FDA last month alerted clinical laboratory staff and health care providers to the potential for false positive results and recommended they consider presumptive any positive results from the tests, among other actions. Only laboratories certified to perform moderate or high complexity tests under the Clinical Laboratory Improvement Amendments can use these test kits.