Nov 12, 2021
Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week.
Nov 1, 2021
Health care providers should not purchase or use certain imported medical gloves from certain companies, which appear to have been reprocessed, cleaned or recycled and sold as new, the Food and Drug Administration announced.
Oct 29, 2021
The Food and Drug Administration announced a Class 1 recall of battery packs for an intra-aortic balloon pump used with patients undergoing surgery and to treat adults with acute coronary syndrome or heart failure complications.
Oct 18, 2021
The Food and Drug Administration approved the first interchangeable biosimilar product for Humira, a monoclonal antibody used to treat certain inflammatory diseases.
Oct 15, 2021
Abbott Molecular Inc. issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and Aug. 31, 2021, for their potential to give false positive results.
Oct 14, 2021
The Food and Drug Administration and Magellan Diagnostics Inc. expanded the ongoing recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests distributed between Oct. 27, 2020, and Aug. 19, 2021.
Oct 12, 2021
The Food and Drug Administration announced it will withdraw regulations for non-drug manufacturers who produced during the COVID-19 public health emergency alcohol-based hand sanitizer or alcohol for use in hand sanitizers.
Oct 7, 2021
DeRoyal Industries recently recalled more than 2,800 procedure packs distributed in the U.S. that could expose patients to harmful levels of aluminum.
Oct 5, 2021
The Food and Drug Administration authorized the emergency use of a new over-the-counter COVID-19 antigen test. Unlike most antigen tests for at-home use, the new test does not require serial testing, FDA said.
Oct 1, 2021
The Food and Drug Administration approved for marketing a computed tomography imaging device that uses advanced technology to help clinicians better diagnose and treat disease.