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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]
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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 ...
Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.
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]
The Pipeline Flex Devices include a guidewire-based delivery system used to place the implant inside the patient. The FDA says that fractured pieces could be Medtronic Recalls Pipeline Flex ...
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 lawsuit claimed that LG continued to produce and distribute LG G4 and V10 smartphones with the defect, even after it acknowledged the issue, and claimed that LG failed to recall or "offer an adequate remedy to consumers" who bought the two models, nor provide any remedy for devices that fell outside of the one-year warranty period.