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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 FDA to issue a recall.
The OneTouch Ultra 2 Meter is similar in design and operation to the OneTouch Ultra, with features including Before and After Meal Flags, Comments, and a list-style memory recall. This meter also provides 7-day, 14-day, and 30-day averages, with the option of averaging "before meal" or "after meal" records.
Johnson & Johnson's LifeScan unit is recalling all of its OneTouch Verio IQ blood glucose meters in the U.S. At extremely high blood glucose of 1024 mg/dL or higher, the machine just shuts off ...
The FDA has issued a statement following the Class I recall for an IOS app used in ... Customers with any questions or concerns regarding the recall can reach Tandem Diabetes Care Inc. at (877 ...
Four generations of blood glucose meter, c. 1991–2005. Sample sizes vary from 30 to 0.3 μl. Test times vary from 5 seconds to 2 minutes (modern meters typically require less than 15 seconds). A blood glucose meter is an electronic device for measuring the blood glucose level. A relatively small drop of blood is placed on a disposable test ...
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.
Information regarding product labels and the list of products will be provided when available. "The products subject to recall bear establishment numbers '51205 or P-51205' inside or under the ...
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