FDA Warns of False Positive Risks Associated with COVID-19 Test

The FDA has issued a warning about an increased risk of false positive results when using Becton Dickinson (BD)’s SARS-CoV-2 reagents for its BD Max System test.

The test, which received an Emergency Use Authorization from the FDA in April, was found to deliver 3 percent of its results as false positives in a study by an unnamed manufacturer, the FDA warned.

Clinical laboratory staff and healthcare providers should consider confirming results obtained using BD’s test with an alternate authorized test, the agency said.