
the staff of the Ridgewood blog
Franklin Lakes NJ, The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic. A Letter to Clinical Laboratory Staff and Health Care Providers alerting them 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 FDA is working with Becton, Dickinson and Company (BD) to resolve this issue and will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed for new or additional information.