Back in2005, Food and Drug Administration (FDA) has alerted the public to counterfeitblood glucose test strips being sold in the United States claiming differentmodels and under different brands. Upon tracing the origin of thesecounterfeited medicines, the authorities had found same copies distributed indeveloping countries including Jakarta, Indonesia, Bangkok, Thailand and somepart of Northern Australia.
Ten yearslater, the same issue resurfaces.
In aresearch released by The Peterson Group, more than ten states in the countrycontinue to distribute these strips in small quantities.
FDA furtherdelves into the matter and has classifies the current situation as a Class Irecall as some of the operations are reviewed to have significant deviations in performance. The counterfeit test stripspotentially could give incorrect blood glucose values-- either too high or toolow--which might result in a patient taking either too much or too littleinsulin and lead to serious injury or death.
These counterfeitedproducts are said to be branded under the company, Lifescan, one of the mosttrusted companies when it comes to medical strips and other related products.FDA stand resolute on the factor that the products of concern are counterfeit –they are not marketed or distributed by Lifescan, and Lifescan is notresponsible for conducting the recall. Rather, firms that are distributing thecounterfeit product are responsible for conducting the recall using correctiveactions developed by Lifescan, with input from FDA. FDA continues to work withLifescan and the distributors to ensure that counterfeit products are removedfrom the market.
Thefollowing strips are said to be counterfeited:
• One Touch® Basic®/Profile® (lot#272894A, 2619932, 2606340, 2615211 (added October 23, 2006) and 227078A (newlot) test strips, and
• One Touch® Ultra® (lot #2691191and 2691261 (added October 23, 2006) test strips.
Experts andspecialists warn on the use of these materials. Testing of these counterfeittest strips has shown unreliable performance that includes highly inaccuratetest results. A wrong result may lead to induction of high or low level ofinsulin which can cause potential harm and even death to a patient. It iscurrently unknown how fraudulent test strips that may be in the marketplacewill perform. LifeScan cannot ensure the accuracy and reliability of bloodglucose test results obtained from test strips it did not manufacture. Use ofthese counterfeit test strips could result in inaccurate test results that maylead to improper treatment.