A malfunction that could pose a serious health risk has compelled Johnson & Johnson subsidiary LifeScan to voluntarily recall and replace all of its OneTouch Verio IQ Meters at no charge to consumers.
According to a letter(www.onetouch.com) from the Milpitas, Calif.-based medical device manufacturer, at extremely high blood glucose levels of 1024 mg/dL or greater, the meter turns off instead of displaying the intended message: "EXTREME HIGH GLUCOSE above 600 mg/dL."
"When turned back on, the meter enters the set-up mode and requires the user to confirm the date and time settings before being able to test again," says the letter. "However, if the glucose level is still 1024 mg/dL or above when testing, the meter will shut down again."
The malfunction can cause a delay in the diagnosis and treatment of extreme hyperglycemia, according to LifeScan, or incorrect treatment may be given as a result of the issue.
The company is asking physicians and other health care professionals to discontinue distributing the meters to patients, collect all sample meters in their possession and call (877) 644-0004 to arrange for pick-up.
The identifying information for the meter is as follows:
- UPC No. 353885007702
- LifeScan Part No. 022267
- NDC No. 53885026701
Consumers who are using the recalled meter are asked to call (800) 717-0276 to verify the meter's serial number and confirm a mailing address to which LifeScan can ship a replacement meter. Product owners may continue to test using their current meter while awaiting a replacement. If, however, the meter unexpectedly turns off and enters set-up mode after being turned back on, this may signal an extremely high glucose reading, and these individuals should call their family physician.