The U.S. FDA said it has issued an emergency use authorization (EUA) for the use of the diagnostic for 2019-NCoV pathogen developed by the Centers for Disease Control and Prevention (CDC). The FDA said the real-time polymerase chain reaction test can be used at any CDC-qualified lab in the U.S. The test requires nasal or oral swabs, but the FDA said a negative outcome should not be seen as precluding infection.
The U.S. FDA said the class I recall of the Carescape respiratory modules by GE Healthcare, of Waukesha, Wis., was prompted by reports of incorrect oxygen values. The incorrect readings are due to manufacturing issues that may lead to hypoxia or hyperoxia, although no injuries or fatalities have been reported. The recall affects 165 units distributed in the U.S. between June 7 and Aug. 16, 2019.