Some blood glucose test strips being sold in the United States are counterfeit and potentially could provide patients with incorrect information on blood glucose values, according to an alert issued by the Food and Drug Administration.
Certain lots of two types of test strips used with different models of OneTouch-brand blood glucose monitors have been found to be counterfeit and are being voluntarily recalled by the manufacturer, LifeScan Inc. The counterfeit test strips are:
▸ OneTouch Basic/Profile (lot #272894A, 2619932, or 2606340) test strips. (The outer cartons of these strips have English, Greek and Portuguese text; and only 50-count packages are affected.)
▸ OneTouch Ultra (lot #2691191) test strips. (The outer cartons of these strips have English and French text; only 50-count packages are affected).
The counterfeit strips were distributed to stores and pharmacies across the country, but primarily were sold in Ohio, New York, Florida, Maryland, and Missouri by Medical Plastic Devices Inc., Pointe Claire, Que.; and Champion Sales Inc., Brooklyn, N.Y, according to the alert.
The FDA is advising consumers to stop using these counterfeit strips if they have purchased them, replace the strips immediately, and call their physicians. The company is advising customers to contact their original source of the strips for restitution.
The FDA, which is investigating this case, has not received any reports of injuries related to the counterfeit strips, but encourages physicians and others to report any adverse reactions associated with the use of this product and/or quality problems to the FDA's MedWatch program at 800-332-1088, or www.fda.gov/medwatch
LifeScan can be reached at 866-621-4855, if consumers have any questions. More information is also available at www.GenuineOneTouch.com