False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System – Letter to Clinical Laboratory Staff and Health Care Providers

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.