The U.S. Food and Drug Administration (FDA) posted an advisory, alerting clinical laboratorians to 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 of results were false positive results, according to the FDA.
A spokesperson for BD (Becton, Dickinson and Company) did not respond to a request from Medical Laboratory Observer (MLO) for comment.
The FDA said it is working with BD to resolve the issue and will keep the lab industry informed as new information becomes available.
In the meantime, FDA officials recommend that lab staff and healthcare providers consider confirming any positive result from tests using the BD SARS-CoV-2 Reagents for the BD Max System with an alternate authorized test.
The FDA granted an emergency use authorization (EUA) for the BD test on April 8, 2020.
