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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.
OneTouch Ultra blood glucose meters provide blood glucose test results in five seconds. The device offers alternative test site options, as well as various memory and flagging features. The results are displayed as plasma values. It is used to measure glucose levels for both hypoglycemia and hyperglycemia in children and adults. [2][3]
Recall information. FDA develops a strategy for each individual recall that sets forth how extensively it will check on a company's performance in recalling the product in question. For a Class I recall, for example, FDA would check to make sure that each defective product has been recalled or reconditioned. In contrast, for a Class III recall ...
LifeScan was established in 1981. [3] It was acquired by Johnson & Johnson (J&J) in 1986, [2][4] and in June 2018, J&J agreed to sell LifeScan to Platinum Equity as part of its strategic exit from the diabetes device market, accepting an offer originally tendered in March 2018. [1] The divestiture completed in October 2018. [1][5]
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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 ...
Drug recall. A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug ...
The California-based medical device maker started the recall process on Nov. 20 and has recalled over 20 mill US FDA identifies recall of ResMed's respiratory devices as most serious Skip to main ...