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FDA warning labs of COVID-19 test with false positive results

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Posted at 3:19 PM, Jul 08, 2020
and last updated 2020-07-08 15:19:21-04

The U.S. Food and Drug Administration is warning clinical labs and healthcare providers that a common COVID-19 test is providing false positive results.

According to the FDA, the BD Max System COVID-19 diagnostic test from Becton Dickinson is showing an error rate of 3% false positives.

The nasal swab based test was given an emergency authorization from the FDA on April 8.

Now, the FDA is recommending that patients confirm their results with an alternative authorized test.

In addition, the FDA is working with Becton, Dickinson and Company to quickly resolve this issue.

The FDA says it will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed of new or additional information.

Click here for more information about the FDA's warning.