FDA Letter Warns of False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System

On July 6, 2020, the U.S. Food and Drug Administration (FDA) alerted 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.

The FDA recommends clinical laboratory staff and health care providers:

• Consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System. Consider confirming with an alternate authorized test.
• Report any issues with using COVID-19 tests to the FDA.

View the complete FDA letter to health care providers.