LOS ANGELES - The U.S. Food and Drug Administration issued a warning letter for clinical labs and health care providers over COVID-19 tests manufactured by global medical technology company Becton, Dickinson and Company (BD) which has produced coronavirus tests the department says are at high risk for false positive results.
In a study conducted by the company and cited by the FDA, approximately 3% of results from tests using the BD SARS-CoV-2 Reagents for the BD Max System were false positive results.
In its letter, the FDA wrote, “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.