The U.S. Food and Drug Administration sent a public alert on Friday that created quite a stir, against the fake versions of test strips normally used to monitor blood sugar levels in glucose monitors manufactured by a Johnson & Johnson company.
"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," an FDA statement said.
"Diabetics who purchased the counterfeit test strips should stop using them, replace them immediately and call a doctor, " the FDA said.
Several models of LifeScan Inc.'s OneTouch brand of blood glucose monitors make use of the counterfeit test strips. LifeScan is division of New Brunswick, a Johnson & Johnson working unit based in New Jersey.
One batch of the fake strips was sold under the brand One Touch Basic Profile with lot numbers 272894A, 2619932 or 2606340 with English, Greek and Portuguese writing on the carton. One more batch of the fake strips was sold under the brand One Touch Ultra with the lot number 2691191 and writings in English and French on the carton.
"The fake test strips were sold in 50-count packages," the FDA said.
Both the FDA and the company officials are not at ease in detecting the actual number of phony strips already distributed and what is more painful is that a huge mass in the U.S. is under danger.
According to a source in FDA, Medical Plastic Devices Inc., of Quebec, Canada and Champion Sales Inc., of Brooklyn, New York distributed most of the phony strips mainly in Ohio, New York, Florida, Maryland and Missouri.
"Lifescan had immediately notified the FDA once it learned about the counterfeit test strips and is vigorously pursuing legal actions," said LifeScan.
To give answer to the incident LifeScan delivered a press release, which says "Performance testing of the counterfeit test strips obtained by LifeScan to date shows erratic test results that do not meet LifeScan's performance specifications. It is unknown how counterfeit test strips which 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. "