False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System - Letter to Clinical Laboratory Staff and Health Care Providers
On March 10, 2021, based on new data provided by Becton, Dickinson and Company (BD), the FDA reissued the EUA for the BD SARS-CoV-2 Reagents for the BD Max System test, and the test no longer has an increased risk of false positive results.
For updated labeling, including results of a post-authorization study, see the Instructions for Use. Accordingly, all safety concerns listed on this page have been resolved and the previous recommendations for clinical laboratory staff and health care providers no longer apply to the BD SARS-CoV-2 Reagents for the BD Max System test.
The U.S. Food and Drug Administration (FDA) is alerting 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.
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.
Contact Information
If you have questions about this letter, contact [email protected].