Press Releases and notifications
August 31, 2011
Updated Important Note—FreeStyle Navigator Continuous Glucose Monitoring System U.S. Customers
As you may be aware, Abbott Diabetes Care has been experiencing a supply interruption in the United States with the FreeStyle Navigator Continuous Glucose Monitoring System. This interruption has affected our ability to provide U.S. patients with new system kits or warranty replacement components.
We are committed to producing high quality, safe and effective products and to providing the best possible customer service. When we bring a product to market, it is our responsibility to consistently provide the product to customers. In the U.S. we have not been able to consistently supply the Freestyle Navigator System to patients.
As a result, Abbott is permanently discontinuing the FreeStyle Navigator System in the U.S. We understand this decision may affect how some patients manage their blood glucose and we have several options available to help FreeStyle Navigator System patients in the U.S. transition to alternative glucose monitoring technologies.
The discontinuation of the FreeStyle Navigator System in the U.S. is not for safety reasons. The System is safe and effective and continues to be available to patients in seven other markets outside the U.S. No other Abbott Diabetes Care or FreeStyle products are affected by this discontinuation. The discontinuation of the FreeStyle Navigator System in the U.S. will be conducted in an orderly manner and Abbott will provide U.S. customers with options available through March 2012 that can help with the transition to alternative products. Customers who wish to learn about the available options should contact Abbott Diabetes Care customer service at 1- 800-221-7700 for assistance.
We know FreeStyle Navigator System customers in the U.S. have lived with some uncertainty and frustration. We are grateful for the commitment patients and providers have devoted to the FreeStyle Navigator System over the years, and we are sorry that we have been unable to consistently meet their needs.
ADC remains committed to glucose monitoring and to developing other highly innovative glucose monitoring products based on the sensing technology that is at the heart of the FreeStyle Navigator System.
Abbott Diabetes Care is working with the U.S. Food and Drug Administration, Office of Criminal Investigations, the Federal Bureau of Investigation and other law enforcement officials to recover one tractor-trailer shipment of blood glucose monitoring products that was reported stolen from a shipping carrier facility in Louisville, KY. on June 19.
Practitioners, pharmacies, and consumers are advised to purchase Abbott Diabetes Care blood glucose monitoring products only from well established, trusted, and reputable sources and to be aware that an unusually low price is often an indication that a product has been stolen. Stolen blood glucose monitoring products may be harmful because they may have been stored at the wrong temperature or humidity or other improper conditions, may degrade, become contaminated, or may have been tampered with or handled improperly while outside of the legitimate supply chain.
Customers should always inspect blood glucose monitoring products and labels for the Expiration Date and for signs of tampering before opening. Abbott Diabetes Care products are packaged in “tamper-evident” boxes, meaning that if the package has been opened, it should be evident. Abbott Diabetes Care advises customers not to use any product if the packaging appears to have been disturbed in any way.
Products and quantities stolen are listed below. Lot numbers are printed on the products boxes. In nearly every instance, these products represent only a portion of each product lot.
* If customers obtain test strips from the following four lots: FreeStyle Lite Blood Glucose Test Strips (Part Number 71026-20, Lot Numbers: 1165954, 116006, 1166016) or Precision Xtra Blood Glucose Test Strips (Part Number 996994-35 Lot Number 45001F526) they should not use these test strips and are advised to immediately call Abbott Diabetes Care Customer Service at 1-888-522-5226 to have their test strips replaced free of charge. Almost all test strips from the lots were on the stolen tractor-trailer and the remaining test strips from these lots are in Abbott’s control.
Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the product in question after June 19 is advised to contact the U.S. Food and Drug Adminstration Office of Criminal Investigations at 1-800-551-3989 or by visiting the OCI website www.fda.gov/OCI.
If customers have questions regarding these Abbott Diabetes Care products, please call 1-888-522-5226.