Abbott recalls FreeStyle InsuLinx glucose meters

May 22, 2013

Due to a recurring error that sometimes prompts FreeStyle InsuLinx Blood Glucose Meters to display false test readings, Abbott Diabetes Care has voluntarily recalled the product.

 

Due to a recurring error that sometimes prompts FreeStyle InsuLinx Blood Glucose Meters to display false test readings, Abbott Diabetes Care has voluntarily recalled the product.

At certain, extremely high glucose levels, the FreeStyle meters store and display incorrect test results that are 1024 mg/dL below the measured result.  

“Our first priority is to safeguard the health and safety of patients," said Heather Mason, Abbott Diabetes Care’s senior vice president. "We are committed to ensuring that our customers are able to continue to test their blood glucose with confidence, and we initiated this voluntary recall to ensure our products continue to meet the highest standards of quality and safety."

The FreeStyle InsuLinx glucose meters were distributed from April 18, 2012 to April 1, 2013.

Consumers are urged to visit www.freestyleinsulinx.com/swupdate for a free software download that will solve the problem. They can also contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to return their FreeStyle InsuLinx meter at no charge and to receive a new one. Pharmacists and other healthcare professionals should immediately stop dispensing them.

 

"Patient safety must be a priority in the management of diabetes-even though cost and utilization of resources becomes a burden on the healthcare system whenever there is a recall," said Mary Choy, PharmD, CGP, president, New York City Society of Health-System Pharmacists and assistant professor, Touro College of Pharmacy, clinical pharmacist, Metropolitan Hospital. "With the most recent recall on another brand glucometer just merely a month ago, it truly amplifies concern for the diabetic patient. Additional safety measures must be put into place to routinely assess the accuracy of these devices."