Johnson & Johnson said it is recalling and replacing more than two million meters worldwide.
Burnaby, B.C.-based LifeScan Inc., which distributed the products in Canada, also announced its voluntary recall on Monday, saying the defect could potentially lead to delays and incorrect treatment.
"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," the company said in a statement.
Because these products do not provide an appropriate warning at glucose levels of 56.8 mmol/L or higher, diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risks or fatality."
LifeScan estimated that there are about 60,000 active users of the device in Canada.
To date, no adverse events or patient injuries related to this specific issue have been reported, the company said.
In the U.S., the recall affects about 90,000 meters.
The U.S. company said its One Touch Ultra model is not affected.
LifeScan says anyone with the One Touch Verio IQ should call their customer service line at 1 (855) 293-5075 to arrange a replacement meter at no charge. The company also has more information on its website at onetouch.ca.
LifeScan has notified Health Canada and healthcare authorities around the world.
J & J is also recalling about 670,000 of its One Touch Verio Pro meters in Europe and 4,900 of its One Touch Verio Pro+ meters from hospitals in the Middle East, Europe and Asia/Pacific region.
The products are trademarks of Johnson & Johnson.