Johnson & Johnson is remembering and changing nearly two million meters used to calculate blood sugar levels in diabetics due to a failure to operate properly at extremely high glucose readings, the industry’s LifeScan unit stated on Wednesday.
In the USA, about 90,000 OneTouch Verio IQ meters are affected out of some 1.2 million units of that model being were recalled worldwide, the corporation stated.
At very high glucose readings of 1024 mg/dl and above, the units have failed to provide a alert of dangerously high blood sugar and will shut off, potentially delaying proper treatment, the corporation mentioned.
LifeScan stated it has notified the U.S. 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 client injuries have been claimed in the United States associated to the malfunction, the corporation explained. LifeScan stated there was one statement of a serious adverse event outside the United States, however a link to the malfunctioning glucose meter had not been decided.
"We repent the trouble these actions may cause. But, we will always err on the side of extreme caution and create a selection that is in the best attention of our patients," Michael Pfeifer, LifeScan's chief medical officer, stated in a declaration.
The company said its OneTouch Ultra model was not affected by the recall.
It stated clients could continue on to use the Verio IQ model till replacements arrive as long as they are informed that if the unit shuts down it might be indicative of alarmingly higher glucose ranges.
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