Products
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.
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.
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.
DeRoyal Industries recently recalled more than 2,800 procedure packs distributed in the U.S. that could expose patients to harmful levels of aluminum.
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.
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.
The White House Office of the United States Trade Representative extended through Nov. 14 tariff exemptions for certain medical care products needed to address the COVID-19 pandemic while it considers “further extensions and/or modifications as appropriate."
The Food and Drug Administration approved the first biosimilar to treat neovascular age-related macular degeneration, a leading cause of vision loss and blindness for seniors.
Health care providers and patients should not use compounded products marketed as sterile by Greenpark Compounding Pharmacy due to a lack of sterility assurance, the Food and Drug Administration announced.
Health care providers should immediately stop using and discard all ultrasound gel and lotion products made by Eco-Med Pharmaceutical Inc. due to potential bacterial contamination with Burkholderia cepacia complex, the Food and Drug Administration said in an update.