A Medical Device Daily

The FDA has issued an alert concerning counterfeit blood glucose test strips being sold in the U.S. for use with various models of One Touch Brand Blood Glucose Monitors made by LifeScan (Milpitas, California), a business of Johnson & Johnson (J&J; New Brunswick, New Jersey).

The agency said that the counterfeit test strips could give incorrect blood glucose values — either too high or too low — which could result in a patient taking either too much or too little insulin and lead to injury or death.

It said it has received no reports of injuries but that it is investigating the matter.

The counterfeit test strips are: One Touch Basic/Profile (lot #272894A, 2619932 or 2606340) test strips; and, One Touch Ultra (lot #2691191) test strips.

LifeScan issued a press statement warning the public concerning the counterfeit products and said it is notifying pharmacists, distributors and wholesalers through a letter.