False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System No Longer an Issue

Angie Szumlinski Announcements

On March 10, 2021, based on new data provided by Becton, Dickinson and Company (BD), the FDA reissued the EUA for the BD SARS-CoV-2 Reagents for the BD Max System test, and the test no longer has an increased risk of false positive results.  

For updated labeling, including results of a post-authorization study, see the Instructions for Use. Accordingly, all safety concerns listed on this page have been resolved and the previous recommendations for clinical laboratory staff and health care providers no longer apply to the BD SARS-CoV-2 Reagents for the BD Max System test. 

You can read the FDA’s actions and background regarding this test on their website.