Abbott’s COVID-19 Tests Recalled Due to False Positives

The FDA has issued a further update on Abbott Molecular’s Sept. 2 recall of its Alinity COVID-19 test kits, which the agency has deemed a Class 1 recall because of the risk of serious injury or death.

The reason for the recall of the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit is the possibility of false positive results. The FDA said 187 software installations used to automate testing are currently being corrected. 

There have been 9,964,224 distributed tests for the Alinity m SARS-CoV-2 Amp Kit (51,897 kits) and 48,192 distributed tests for the Alinity m Resp-4-Plex AMP Kit (251 kits), the agency said.