Inspections, Compliance, Enforcement, and Criminal Investigations
Information Notice on Stolen Abbott Diabetes Care Blood Glucose Monitoring Products
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Date Posted: June 27, 2011
ALAMEDA, Calif., June 24, 2011 –– 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 product 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, 1166006, 1166016) or Precision Xtra Blood Glucose Test Strips (Part Number 99694-35, 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 these 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 Administration 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.