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FROM: Crispin L. Frame - U.S. FDA says Empowered Diagnostics recalling COVID-19 tests

U.S. FDA says Empowered Diagnostics recalling COVID-19 tests



Jan 28 (Reuters) - Empowered Diagnostics LLC is recalling its COVID-19 tests as they have not been cleared for use in the United States and could potentially lead to false results, the U.S. Food and Drug Administration (FDA) said on Friday.

The regulator has labeled the recall of the CovClear COVID-19 rapid antigen test and the ImmunoPass COVID-19 neutralizing antibody rapid test as Class 1, or the most serious type of recall.


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