"Our first priority is to safeguard the health and safety of patients," said Heather Mason, senior vice president, Diabetes Care, Abbott. "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. We regret any inconvenience this action may cause."
The company is notifying all registered users, healthcare professionals, pharmacies and distributors where the FreeStyle InsuLinx Meter is sold. Abbott estimates that there are approximately 50,000 active FreeStyle InsuLinx Meter users in the United States. Upon identifying the issue, Abbott promptly developed and implemented an update to the meter.
In the United States
To date, there has been one reported patient incident in the United States that may be related to this specific issue. The patient sought medical treatment, was diagnosed with hyperglycemia, treated and released. It has not been determined that the FreeStyle InsuLinx Meter was the cause.Outside the United States Outside the United States, there have been no patient incidents reported related to this specific issue. The FreeStyle InsuLinx meter is available in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom. Customers in these countries can get more information about how to address this issue by visiting www.freestyleinsulinx.com/swupdate. Abbott has notified the U.S. Food and Drug Administration and all relevant healthcare authorities in the other countries. Abbott is working with the individual regulatory agencies around the world where the affected products have been sold.