- The Washington Times - Friday, December 15, 2006

The Food and Drug Administration yesterday issued a “nationwide alert” and recall of counterfeit blood glucose test strips, which could harm diabetics by providing “erratic” blood-sugar readings.

“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,” the FDA said in an advisory on its Web site.

Yesterday’s alert was an update of notifications the FDA issued Oct. 13 and Oct. 23 about counterfeit blood glucose test strips being sold in the United States for use with various models of One Touch blood glucose monitors, produced by LifeScan Inc., a Johnson & Johnson Co. located near San Jose, Calif.

The FDA said it updated its warning after learning from LifeScan earlier this month that an additional lot of phony test strips had been discovered.

Both the government and LifeScan identified the counterfeit test strips as follows: One Touch Ultra test strips, lots 2691191 and 2691261; and One Touch Basic/Profile test strips, lots 227078A; 2606340; 2619932; 272894A; and 2615211.

Diabetics with these test kits should stop using them and call LifeScan (800/227-8862), their doctor, and the FDA’s MedWatch program (800/FDA-1088) to report problems.

LifeScan spokesman Dave Detmers said yesterday the company first learned of the bogus test strips last fall “through a combination of market surveillance and customer complaints” and immediately contacted the FDA.

Attempts yesterday to determine the number of complaints LifeScan has received to date and reports of any “adverse events” were unsuccessful.

The only positive news, Mr. Detmers said, is that the phonies “represent a very small portion of what we believe is out there” in terms of total One Touch test strip inventory.

As for the scam itself, he said yesterday: “It involves both distributors and at least one manufacturer.” Mr. Detmers declined to identify potential suspects.



Click to Read More

Click to Hide