Diabetes: J&J recalls OneTouch Verio IQ glucose meters over failure to warn at extreme levels

April 3, 2013 by Arezu Sarvestani

Johnson & Johnson's OneTouch Verio IQ blood glucose meters were found to shut off at extremely high glucose levels, prompting a recall of all lots of the device.

Johnson & Johnson, LifeScan OneTouch Verio IQ blood glucose meters

Healthcare giant Johnson & Johnson (NYSE:JNJ) recalled all lots of its Verio IQ glucose meters over concerns that the device will fail to warn a diabetic patient in the extremely rare case of a blood glucose level higher than 56.8 mmol/L, or 1023 milligrams per deciliter.

Rather than displaying the intended "EXTREME HIGH GLUCOSE above 33.3 mmol/L" warning, the Verio IQ systems initiate a countdown and then turn themselves off, according to a Health Canada warning.

J&J through its LifeScan Europe division recalled all lots of the affected devices, a move that Canadian healthcare regulators deemed a Class II, deemed "a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote."

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The recalled device appears to work normally the vast majority of the time, requiring the truly extreme blood glucose levels to exhibit a failure. Normal blood glucose levels range from 70 to 180 mg/dL from fasting levels to just after meals, according to the American Diabetes Assn.