Regulatory News In Brief

Johnson & Johnson/LifeScan Inc. announced a global recall and replacement of approximately 1.9 million blood glucose meters March 25. The firm is recalling1.2 million OneTouchVerioIQ blood glucose meters in the U.S., Canada, Asia/Pacific and Europe, 90,000 of which are in the U.S. The company initiated the recall after it discovered the meter may not provide a warning that the blood glucose is extremely high at blood glucose levels of 1,024 mg/dL and above, which could delay or misdirect the diagnosis and treatment of extreme hyperglycemia, resulting in potentially serious health risks or fatality, the firm says. LifeScan notes that the likelihood of reaching a blood glucose level that high is remote. Notifications have been sent to users, health care professionals, pharmacies and distributors. As of March 25, no adverse events or patient injuries related to this issue were reported to LifeScan. The company is in the process of implementing an update to the meter, but has not determined when it will resume shipments.