Johnson & Johnson has issued a voluntary recall involving nearly 2 million blood glucose meters worldwide, due to a potential risk that they may fail to operate correctly at high blood glucose levels.
A OneTouch Verio IQ Blood Glucose Meter recall was announced on Monday by Johnson & Johnson’s Lifescan unit, after the company discovered that the device may not provide a warning when reading high blood glucose levels of 1024 mg/dL.
As a result of the blood glucose meter problems, the device may shut off. This may lead to an incorrect reading and could cause improper or delayed treatment in serious cases.
The recall affects the OneTouch Verio IQ Blood Glucose Meter in the United States and the OneTouch Verio IQ, OneTouch Verio Pro and OneTouch Verio Pro+ meters sold globally.
Although no injuries have been reported as a result of the recall in the United States, at least one adverse event was reported outside of the U.S. in connection to the Verio Pro model. However the OneTouch meter has not been found to be the cause of the injury at this time.
“Our patients’ safety is our number one priority,” said Dr. Michael Pfeifer, LifeScan’s Chief Medical Officer. “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.”
High blood sugar levels can result in severe side effects including blindness, kidney failure, leg amputation, damage to the heart, kidneys and other organs and may even result in death in extreme cases. Doctors recommend a peak blood sugar level of 160 mg/dL following a meal. While it is very rare to experience blood glucose levels above 1024 mg/dL, these are the levels of excess blood sugar which would cause the most severe side effects and require immediate medical attention.
Johnson & Johnson has indicated that it will provide a replacement meter for those with recalled units, and recommends that patients continue testing their blood sugar while waiting for a replacement. However, they should be aware that if the meter unexpectedly turns off, it may be a warning sign of extremely high blood sugar levels, which would require immediate medical attention.
Notifications were sent to all registered users, healthcare professionals, pharmacies and distributors of the meters. Customers can also contact LifeScan Customer Service by calling (800) 717-0276, or by visiting the company’s website at www.onetouch.com.