News and Updates
Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Healthcare Providers
The U.S. Food and Drug Administration (FDA) recommends that healthcare providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been
Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019 (COVID-19)
Summary Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death. Clinicians and public health officials should discourage the public
BodyGuard Infusion Pump System by CME America – Class I Recall
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product BodyGuard Infusion
Class II Recall of Ten Lots of the Revaclear Capillary Dialyzer 300, Product Code 114745L
The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions. Lot Numbers
Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and
Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Volumat MC
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