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."
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.
No patient injuries associated with the missing warning have yet been reported, according to a J&J statement.
"The likelihood of experiencing blood glucose levels of 56.8 mmol/L and above is remote. However, such levels pose a serious health risk to the patient and require immediate medical attention," according to a Verio IQ warning issued by Australian healthcare authorities. "The identified fault in the OneTouch Verio IQ Blood Glucose Meter could lead to a delay in diagnosis and treatment of extremely high blood glucose levels and, consequently, result in serious injury."
J&J launched a "consumer-level" recall and has offered to replace all affected devices free of charge, according to Australia’s Therapeutic Goods Administration.
The news, the latest in a string of recalls of J&J products, didn’t stir much in the way of Wall Street reactions.
J&J late last month announced a recall of all Verio IQ systems, which number about 90,000 in the U.S. alone, according to the healthcare company. No figures were reported for outside-the-U.S. recalls, but J&J noted that the international action includes 3 Verio models: OneTouch Verio IQ, OneTouch® Verio Pro and OneTouch Verio Pro+.
JNJ shares have performed rather well since news of the latest recall, increasing 2.8% since J&J issued a statement on the recall on March 25.