A unit of Abbott Laboratories is recalling two Covid-19 laboratory test kits as they can potentially issue false positive results, the U.S. Food and Drug Administration said on Oct. 14.
U.S. companies are scrambling to boost production of coronavirus tests increasingly in short supply as Covid-19 cases soar and schools and employers revive surveillance programs that will require tens of millions of tests, according to industry executives and state health officials.
The U.S. Food and Drug Administration approved Abbott’s Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.
Abbott Laboratories will pay $160 million to resolve claims that two of the company’s units submitted false claims to Medicare by providing kickbacks to diabetes patients, including “free” or “no cost” glucose monitors, the U.S. Department of Justice said.
St. Jude Medical, which was acquired by Abbott Laboratories in 2017, agreed to pay $27 million to settle allegations the company knowingly sold defective heart devices, the U.S. Justice Department said on July 8.
Abbott’s Xience family of stents received U.S. Food and Drug Administration approval for one-month (as short as 28 days) dual anti-platelet therapy labeling for high bleeding risk patients in the United States.
New mutations, or variants, of the SARS-CoV-2 virus that causes Covid-19 are continuing to be discovered. Health officials in Florida cited a new mutation of the Brazilian strain (P.1) that they are calling P2 or P.1.1.
CVS Health Corp. said on April 19 it will offer three over-the-counter Covid-19 tests at drugstores as well as online, expanding access to home testing in the United States.
Abbott received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for over-the-counter, non-prescription, asymptomatic use of the company’s BinaxNOW COVID-19 Ag Self Test for detection of COVID-19 infection.
Abbott on March 11 announced the formation of the Abbott Pandemic Defense Coalition, a first-of-its-kind global scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats.