The agency is alerting clinical laboratory staff and healthcare providers to the risk after a study in which the manufacturer found that approximately 3% of results from the BD SARS-CoV-2 reagents test for COVID-19 were false positives.
According to the statement, the FDA suggests that lab staff and healthcare providers consider any positive result presumptive from tests using the reagents for the BD Max System. They should also consider confirming with an alternate authorized test and report any issues with the tests to the agency.
Becton Dickinson received FDA emergency use authorization (EUA) and CE Mark approval for its COVID-19 molecular diagnostic test in April. The following month, the company said it was ramping up its testing capacity ahead of a potential second wave of COVID-19.
The company also announced today that it received EUA for its COVID-19 antigen test, which it will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run on BD’s Veritor instruments and BD says about 25,000 Veritors are already installed at healthcare providers and pharmacies across the U.S.
In the meantime, the FDA says it is working with BD to resolve the issue with the false positives and will continue to keep lab staff, healthcare providers, manufacturers and the public up to date on new or additional information.
Becton Dickinson did not immediately respond to a request for comment. This story may be updated.