|Johnson & Johnson is recalling its VerioIQ glucose monitor.--Courtesy of Johnson & Johnson|
Johnson & Johnson ($JNJ) is recalling a model of its market-leading LifeScan glucose meters, warning that the devices shut down when confronted with dangerously high blood sugar levels.
The OneTouch VerioIQ meter is incapable of warning patients whose blood glucose soars above 1024 mg/dL, levels that require immediate medical attention. Using the device with blood glucose that high could lead to improper diagnosis or delayed treatment, resulting in injury or death, J&J said.
About 90,000 patients use the VerioIQ meter in the U.S., according to J&J, and the company is asking customers to reach out and sign up to receive a replacement device. In the meantime, J&J is advising patients to keep testing with VerioIQ but be aware that a shutdown could be a sign of a serious issue. J&J is planning to update the meters and rectify the issue, but it hasn't sent a timeline for sending out replacements.
"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," LifeScan CMO Michael Pfeifer said in a statement. "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."
So far, J&J has heard word of only one serious adverse event, outside the U.S., and the company is yet to determine whether its device is to blame. J&J didn't disclose how much money it expects to lose with the recall, but with VerioIQ retailing for $82.50, replacing 90,000 units could mean nearly $7.5 million in lost sales in the U.S. alone.
The FDA is aware of the recall, J&J said, but the agency is yet to weigh in with a class distinction.
- read J&J's statement