The US Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of an increased risk of a false positive result using BD SARS-CoV-2 Reagents for the BD Max System test. In one study, BD found approximately three percent (3%) of results were false positive results.
The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs.
The test received an Emergency Use Authorization on April 8, 2020.
FDA is working with Becton, Dickinson and Company (BD) to resolve this issue. The FDA will continue to keep clinical laboratory staff, health care providers, and the public informed of new or additional information.
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.
