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August 12, 2022

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 11, 2022. To view listings for other dates, see CDRH New - News and Updates.

• At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication
• Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery
• Consumer Information on: SBL-3 Multifocal Intraocular Lens - P200020
• Consumer Information on: ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total 2 Quality Control (HBcT2 QC) - P210019
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Agreement for Shipment of Devices for Sterilization
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Accessories