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A glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin pumps has led to over 200 injuries, prompting the U.S. Food and Drug Administration to issue a recall.
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Roche acquired Syntex in 1994, and Chugai Pharmaceuticals in 2002. Oseltamivir an antiviral drug used to combat influenza. Roche is the only drug company authorized to manufacture the drug, which was discovered by Gilead Sciences. Roche purchased the rights to the drug in 1996, and in 2005, settled a royalty dispute, agreeing to pay Gilead ...
In November 2011, the company received FDA clearance to market the t:slim Insulin Pump, the first ever touch-screen insulin pump. [10] In February 2013, the company received FDA clearance to market the t:connect Diabetes Management Application, a Mac and PC-compatible data management application that provides t:slim Pump users and their healthcare providers a way to display data from the pump ...
Mylan’s second recall of Insulin Glargine this year. For premium support please call: 800-290-4726 more ways to reach us
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