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  1. Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

2022 Safety Communications

Device Name Date
Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication 05/10/2022
Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication 04/19/2022
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication 04/05/2022
Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication 03/18/2022
FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication 03/14/2022
Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication 03/01/2022
Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication 03/01/2022
Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication 03/01/2022
Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication 02/08/2022
Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication 02/04/2022
Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication 01/28/2022
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems - FDA Safety Communication 01/13/2022
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication 01/11/2022

 

 

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