At extremely high glucose readings of 1024 mg/dl and above, the units have failed to provide a warning of dangerously high blood sugar levels and will shut off, potentially delaying proper diabetes treatment, the company said.
Recommendations from the FDA
LifeScan said it has notified the US Food and Drug Administration and other health regulators of the voluntary recall, as well as registered users and healthcare professionals. In addition to the Verio IQ model, J&J is also recalling about 670 000 of its OneTouch Verio Pro meters in Europe and 4 900 of its hospital-based OneTouch Verio Pro+ meters in the Middle East, Europe and the Asia/Pacific region.
No patient injuries have been reported in the United States related to the malfunction, the company said. LifeScan said there was one report of a serious adverse event outside the United States, but a link to the malfunctioning glucose meter had not been determined."We regret the inconvenience these actions may cause.
However, we will always err on the side of caution and make a decision that is in the best interest of our patients," Michael Pfeifer, LifeScan's chief medical officer, said in a statement.
The company said its OneTouch Ultra model was not affected by the recall. It said patients could continue to use the Verio IQ model until replacements arrive as long as they are aware that if the unit shuts down it could be indicative of dangerously high glucose levels.