October 1, 2020,

The National Agency for Food and Drug Administration and Control has received information from the US FDA on 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.

The BD SARS-CoV-2 Reagents for BD Max System test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. This warning only applies to the BD SARS-CoV-2 Reagents for the BD Max System.

Recommendations

Healthcare providers should;

• 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 NAFDAC

Healthcare professionals are encouraged to report any adverse events or suspected adverse events experienced with tests using the BD SARS-CoV-2 Reagents for the BD Max System to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management