FDA warns labs of potential false positive COVID-19 results with BD Max System

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.

WINK News reached out to local testing sites. We can confirm, the CenturyLink Sports Complex site does not use the BD Max System tests. We are still awaiting a reply from other testing sites.

Recommendations

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. See Reporting Problems to the FDA below.

Background

The BD SARS-CoV-2 Reagents for BD Max System test is only authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests. The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. This letter only applies to the BD SARS-CoV-2 Reagents for the BD Max System.

The test received an Emergency Use Authorization on April 8, 2020.

FDA Actions

The 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, manufacturers, and the public informed of new or additional information.
Additional Resources

• 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

Reporting Problems to the FDA

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 requirements should follow the reporting procedures established by their organizations.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.