A Medical Device Daily

The FDA late last week provided an update to its Oct. 13 and Oct. 23 notifications, alerting the public to counterfeit blood glucose test strips being sold in the U.S. for use with various models of One Touch Brand Blood Glucose Monitors from LifeScan (Milpitas, CA). These test strips are used by people with diabetes to measure their blood glucose.

The update includes an additional lot number that is being distributed, along with a description of how to identify the new lot.

FDA has classified the current situation as a Class I recall because some of the counterfeit products, it said, have "significant deviations" in performance. The counterfeit test strips potentially could give incorrect blood glucose values — too high or too low — which could result in a patient taking either too much or too little insulin and lead to serious injury or death.

The products of concern are counterfeit, the FDA emphasized; 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 said it continues to work with Lifescan and product distributors to ensure removal of the counterfeit products from the market.

The counterfeit test strips are:

  • 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.

LifeScan alerted FDA concerning the new lot of counterfeit test strips, and the agency said it continues to investigate the matter, including whether there have been any adverse events associated with the counterfeits which were distributed to pharmacies and stores nationwide. On Oct. 13, 2006 (later updated Oct. 23), FDA also alerted its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this information.