Johnson & Johnson announced that it initiated a voluntary recall of almost two million its OneTouch Verio IQ blood glucose meters.
According to the company, the OneTouch Verio IQ Meters may respond improperly in the presence of very high blood glucose levels that exceed 1024 mg/dL. Above this blood glucose level, the affected meters will not provide a warning. Instead, the devices will shut off.
While hyperglycemia resulting in blood glucose levels above 1024 mg/dL is extremely rare, this condition requires immediate medical attention. Since the meter may not provide proper warning of dangerously-high blood glucose levels, the malfunctioning devices could lead to a delay in receiving medical attention. This could potentially lead to serious injury or death.
Johnson & Johnson is recalling an estimated 1.2 million meters sold internationally under the name OneTouch Verio IQ. The company estimates that there are 90,000 active OneTouch Verio IQ meter patients in the United States. Notifications are being sent to all registered users of the device. In addition, pharmacies, distributors and healthcare professionals are being alerted to the voluntary recall. The company stated that it is in the process of updating the meter to resolve the issue.
In addition, J&J is recalling 670,000 OneTouch Verio Pro meters in Europe. The company is also recalling approximately 4900 OneTouch Verio Pro + meters sold outside of the United States.
Dr. Michael Pfeifer is the chief medical officer at LifeScan. In prepared remarks, he said, "Our patients' safety is our number one priority." He continued, "When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. 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."
More on the recall:
More from the recall front: