False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System

The FDA is working with Becton Dickinson and Company (BD) to resolve this issue. The FDA will continue to keep clinical laboratory staff, healthcare providers, manufacturers, and the public informed of new or additional information

The US Food and Drug Administration (FDA) has been 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 that approximately three per cent of results were false-positive results.

The FDA recommends clinical laboratory staff and healthcare 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 authorised test.
• Report any issues with using COVID-19 tests to the FDA. See Reporting Problems to the FDA below.

As per the FDA, the BD SARS-CoV-2 Reagents for BD Max System test is only authorised 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.

The FDA is working with Becton Dickinson and Company (BD) to resolve this issue. The FDA will continue to keep clinical laboratory staff, healthcare providers, manufacturers, and the public informed of new or additional information.

• 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 healthcare 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 programme.
• Device manufacturers and user organisations must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by organisations that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their organisations.

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