The FDA is alerting clinical laboratory staff and healthcare 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 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.
Read more from the FDA.