LifeScan, Inc., a leading manufacturer of blood glucose monitoring systems for people with diabetes, has announced the immediate recall of a single lot of its OneTouch Ultra brand blood glucose monitoring test strips in India.
An internal investigation of recent customer complaints shows that some test strips in this particular lot do not meet the company's performance standards. Use of these test strips by patients with diabetes could result in inaccurately high blood glucose test results that may lead to improper treatment and possible injury.
While the majority of test strips in this lot will provide accurate test results, the company voluntarily decided to remove and replace this lot of test strips to help ensure patient safety. OneTouch Ultra test strips are used in conjunction with OneTouch Ultra Meters to measure blood glucose levels.
The recalled tests strips were sold in packages of 25 test strips and bear the Lot 2679712 mentioned on the outside of the test strip box and on the label of the test strip vial. All diabetes patients using OneTouch Ultra brand blood glucose meters are requested to check the lot number of their test strips to determine if they have any of these test strips subject to removal and replacement.
According to a company press release, patients with OneTouch Ultra test strips from Lot 2679712 should discontinue their use immediately and call LifeScan Customer Service at 1800225544 (toll free) or 022-30845544 to receive replacement test strips at no charge and instructions for returning their test strips subject to replacement. They can also send an SMS, "JNJ " to 57333 or e-mail to service@lifescanindia.jnj.com.
LifeScan India has notified the DCGI and is conducting a comprehensive notification campaign including patients, healthcare professionals, retailers/pharmacies and distributors, the release added.