The Food and Drug Administration last week announced a Class 1 recall of the Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Test because it may have been distributed to unauthorized laboratories, which could increase the risk of false results. The test is authorized for emergency use only by laboratories certified under the Clinical Laboratory Improvement Amendments. Celltrion last month instructed customers to provide a CLIA certification number or return the test, among other actions.

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