FDA Update: False Positive Results with BD SARS-CoV-2 Reagents

FDA Update – July 8, 2020

False Positive Results with BD SARS-CoV-2 Reagents

This will probably not be the last of these types of notices.

The FDA is alerting clinical laboratory staff and health care professionals of increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In a study, the manufacturer found approximately 3 percent of the results were false positive.

FDA recommendations for clinical laboratory staff and health care providers are:

• 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. See Reporting Problems to the FDA below.

The FDA is working with Becton, Dickinson and Company (BD) to resolve the issue. The FDA will continue to update clinical laboratory staff, health care providers, manufacturers, and the public of new and additional information. Additional resources include:

• Fact Sheet for Health Care Providers: BD SARS-CoV-2 Reagents for BD Max System
• FAQs on Testing for SARS-CoV-2
• In Vitro Diagnostics EUAs

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with tests using the BD SARS-CoV-2 Reagents for the BD Max System.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user organizations must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by organizations that are subject to the FDA’s user facility reporting requirementsshould follow the reporting procedures established by their organizations.

Please visit the FDA’s website for the full news release.

If you are aware of any adverse events, please report to the FDA’s MedWatch Adverse Event Reporting program. For any further questions about this update about SARS-CoV-2 testing, please email mdi Consultants at [email protected] RE: MedWatch.