Johnson & Johnson Issues Recall for OneTouch Verio, Affects 1.2 Million Users Worldwide
Pharmaceutical and medical device company Johnson and Johnson is recalling its OneTouch Verio IQ blood glucose meter. Instead of alerting patients whose blood glucose level is dangerously high, the device simply shuts off.
According to the Associated Press, the meter turns off when the blood glucose level reaches 1,024 milligrams per deciliter, or 56.8 millimoles per liter. At that level, the blood glucose level is dangerous and requires immediate medical attention.
The defect could lead to delays in correct treatment. According to Reuters, the device has only been linked to one adverse reaction in the world, but further investigations are underway to determine whether the defect was responsible. Johnson and Johnson says that the recall is being made out of an abundance of caution.
"The likelihood of experiencing an extremely high blood glucose level of 56.8 mmol/L or higher is remote; however, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention," Johnson and Johnson said in a statement.
According to the CBC, the recall will involve the replacement of 1.2 million meters around the world.
The device is built by the company's LifeScan unit. Consumers should call LifeScan's customer service department at 1-800-717-0276 in order to ask questions or request a free replacement meter.
The recall also affects 670,000 European users of the OneTouch Verio Pro and 4,900 OneTouch Verio Pro Plus in the Middle East, Europe and Asia/Pacific.
In the United States, the recall affects 90,000 users. LifeScan reports that it has already notified the Food and Drug Administration, registered users and practitioners of the voluntary recall.
"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, the chief medical officer of LifeScan, said in a statement.
Johnson and Johnson says that its OneTouch Ultra is not affected by the recall.
This recall is simply the latest in a string of three dozen for the company in the past four years.