LumiraDx Issues Software Update to Address False-Positive Issues with COVID-19 Test

LumiraDx has issued a mandatory software update for its LumiraDx SARS-CoV-2 Antigen Ag Test following a report of false-positive test results given by the diagnostic.

The company determined that a manufacturing problem caused a small number of sequential test strips in certain batches to pose a risk of false-positive results. The software update programs the test to automatically recognize the invalid test strips and instructs the user to discard them.

The company said that approximately 1 percent of the test strips in 24 lots distributed in Europe were affected by the manufacturing issue.