Class I Recall For Haimen Shengbang Viral Sampling Containers
Executive Summary
The US FDA has designated a recall of Haimen Shengbang Laboratory Equipment Co. viral transport media containers as class I, the agency’s most serious designation.
You may also be interested in...
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.
Israeli Company Lands De Novo Clearance For Digital Bone Marrow Application
The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.
More Heartmate Troubles For Abbott. Latest Recall Includes 14 Deaths
Abbott initiated a recall in February of thousands of Heartmate devices due to a system obstruction that can result in serious health outcomes, including death. The FDA has now designated the recall as class I.