The FDA said it’s alerting clinical laboratory staff and health care providers of an increased risk of false positives with BD SARS-CoV-2 Reagents for the BD Max System test.
- In one study, the manufacturer found about 3% of results were false positives, according to a statement on the agency’s website
- The FDA recommends that any positive result using the BD SARS-CoV-2 Reagents for the BD Max System should be considered presumptive
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