AAFES RECALL NO.
06-039 |
| DISTRIBUTION: CONUS NOTE: AAFES IS NOT INVOLVED AS WE DID NOT SELL THE AFFECTED STRIPS. THIS ALERT IS ISSUED FOR OUR PATRONS’ AWARENESS. AAFES sells LifeScan Glucose Monitors and their test strips only. The U.S. Food and Drug Administration (FDA) is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose. LifeScan alerted FDA of the counterfeit test strips. The agency is investigating the matter. HAZARD: The counterfeit test strips potentially could give incorrect blood glucose values--either too high or too low--which might result in a patient taking either too much or too little insulin and lead to serious injury or death. No injuries have been reported to FDA to date. INSTRCUTIIONS TO IDENTIFY: A: One Touch Basic®/Profile®: 50 count test strip packages having lot numbers 272894A, 2619932 or 2606340. The outer package has multiple language texts in English, Greek and Portuguese. B: One Touch Ultra®: 50 count test strip packages with a lot Number 2691191. The outer package has multiple language texts in English, Greek and Portuguese. SOLD AT: The counterfeit test strips were distributed to pharmacies and stores nationwide--but primarily in Ohio, New York, Florida, Maryland and Missouri--by Medical Plastic Devices, Inc., Quebec, Canada and Champion Sales, Inc., Brooklyn, N.Y. AAFES DID NOT SELL THESE STRIPS. INSTRCUTIONS FOR CONSUMERS: Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact the company at 1-866-621-4855 or for more information visit their web site at www.GenuineOneTouch.com. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or through the MedWatch Web site at www.fda.gov/medwatch Home
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