FDA Continues warning on Counterfeit Touch Blood Glucose Test Strips
Back in 2005, Food and Drug Administration (FDA) has alerted the public to counterfeit blood glucose test strips being sold in the United States claiming different models and under different brands. Upon tracing the origin of these counterfeited medicines, the authorities had found same copies distributed in developing countries including Jakarta, Indonesia, Bangkok, Thailand and some part of Northern Australia.
Ten years later, the same issue resurfaces.
In a research released by The Peterson Group, more than ten states in the country continue to distribute these strips in small quantities.
FDA further delves into the matter and has classifies the current situation as a Class I recall as some of the operations are reviewed to have significant deviations in performance. 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.
These counterfeited products are said to be branded under the company, Lifescan, one of the most trusted 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 not responsible for conducting the recall. Rather, firms that are distributing the counterfeit product are responsible for conducting the recall using corrective actions developed by Lifescan, with input from FDA. FDA continues to work with Lifescan and the distributors to ensure that counterfeit products are removed from the market.
The following strips are said to be counterfeited:
• One Touch® Basic®/Profile® (lot #272894A, 2619932, 2606340, 2615211 (added October 23, 2006) and 227078A (new lot) test strips, and
• One Touch® Ultra® (lot #2691191 and 2691261 (added October 23, 2006) test strips.
Experts and specialists warn on the use of these materials. Testing of these counterfeit test strips has shown unreliable performance that includes highly inaccurate test results. A wrong result may lead to induction of high or low level of insulin which can cause potential harm and even death to a patient. It is currently unknown how fraudulent test strips that may be in the marketplace will perform. LifeScan cannot ensure the accuracy and reliability of blood glucose test results obtained from test strips it did not manufacture. Use of these counterfeit test strips could result in inaccurate test results that may lead to improper treatment.