False Positive Results with BD SARS-CoV-2 Reagents for BD Max System

The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false positive results.

The U.S. Food and Drug Administration has issued a warning to labs and healthcare providers alerting of an increased risk of a false positive result with a common Covid-19 currently on the market. The BD Max System diagnostic test from Becton Dickinson has been found to report false positive results in approximately 3% of tests. As a result, the FDA recommends that clinical laboratories and health care providers confirm with alternate authorized tests and report any issues to the FDA.