FDA and Manufacturer Alert: Diabetes Care Products Stolen from Shipping Facility

July 7, 2011 10:12 AM

A shipment of blood glucose monitoring products was stolen from a shipping carrier facility in Louisville, KY, on June 19, 2011, and the manufacturer, Abbott Diabetes Care, is working with the Food and Drug Administration (FDA) Office of Criminal Investigations (OCI), the Federal Bureau of Investigation, and other law enforcement officials to recover the products.

Abbott Diabetes Care and FDA advise pharmacies, patients, and health care providers to ensure that Abbott Diabetes Care blood glucose monitoring products are purchased from well established, trusted, and reputable sources. 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. Further, the manufacturer notes reminders for health care providers and consumers to help ensure the quality and safety of these products:

• an unusually low price often indicates a stolen product
• blood glucose monitoring products and labels should be inspected 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.

Portions of lots of several products are affected and a complete list is available in an Abbott Diabetes Care news release posted on the FDA Web site. Abbott Diabetes Care advises patients not to use test strips from the following four lots:

• FreeStyle Lite Blood Glucose Test Strips
  Part Number 71026-20
  Lot Numbers: 1165954, 1166006, 1166016
• Precision Xtra Blood Glucose Test Strips
  Part Number 99694-35
  Lot Number: 45001F526

If products from these lots have been purchased, patients should immediately call Abbott Diabetes Care Customer Service at 888/522-5226 to have their test strips replaced free of charge. Information regarding the theft, or suspicious and unsolicited offers for the product in question after June 19, 2011, should be reported to the FDA OCI by calling 800/551-3989 or by visiting the OCI Web site.