FDA Warns: Don’t Use CovClear, ImmunoPass COVID-19 Tests; High-Risk Class I Recall Underway
Executive Summary
The US FDA said on 28 January that it’s worried about the potential for false-negative or false-positive results given from the diagnostics, which were made by Empowered Diagnostics. The company has recalled the tests because they weren’t authorized by the agency for use in the US.
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