CDRH New - March 19, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 18, 2020. To view listings for other dates, see CDRH New - News and Updates.

Emergency Use Authorizations - Added Abbott RealTime SARS-CoV-2 assay (Abbott Molecular) Consumer Information on: LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039 Class I Recall: CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion