The LifeScan unit of Johnson & Johnson is voluntarily recalling almost 2 million of its OneTouch Verio blood glucose meters because they malfunction at extremely high blood glucose levels.
The recall includes 1.2 million meters sold worldwide under the brand name OneTouch Verio IQ, says LifeScan spokesperson David Detmers. Of those, 90,000 are in the United States. Also recalled are 670,000 OneTouch Verio Pro meters in Europe, and 4,900 OneTouch Verio Pro + meters used in hospitals and clinics in various markets outside the United States.
Each of the One Touch Verio models malfunction a bit differently at blood glucose levels of 1024 mg/dL and higher.
LifeScan is advising US patients using the OneTouch Verio IQ meter to call 1-800-717-0276 to receive a free replacement. They can continue using their current meter as long as they understand the defect, according to LifeScan. However, an unexpected shutoff during testing could indicate extreme high blood sugar, which warrants contacting a healthcare professional.
The likelihood of anyone experiencing a blood glucose level of 1024 mg/dL is remote, but possible, LifeScan said in a press release. "Because [the OneTouch Verio IQ meters] do not provide an appropriate warning…diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality."
More information about the recall is available on the Johnson & Johnson web site.
To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals.
Robert Lowes - WebMD
