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The agency said false-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals. Read More
According to the FDA, Baxter has received 51 reports of serious injuries and three reports of patient deaths over five years, potentially associated with this problem. Read More
The affected software could cause users to “inadvertently program and confirm a basal rate with an incorrectly placed decimal point,” which could lead to an underdose or overdose of insulin, the company said. Read More
The fault carries a danger of serious adverse events, such as arterial or rupture, ischemia and/or blood vessel complications that could require surgical repair. Read More
So far, the FDA says, it has not received reports of injuries, adverse health consequences or deaths associated with use of ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test. Read More
The tip damage could lead to vascular injuries, including blockage of the vessel, additional blood clots, inadequate blood supply, heart attack, infection or death, the agency said. Read More
To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may be related to the device problem. Read More