The test strips, for use in glucose monitors made by a Johnson & Johnson company, were distributed nationwide, the Food and Drug Administration said in a public alert.
The phony test strips are for use with various models of LifeScan Inc.'s OneTouch brand of blood glucose monitors. LifeScan is part of New Brunswick, N.J.-based Johnson & Johnson.
The counterfeit test strips could give incorrect blood glucose values, leading patients to take too little or too much insulin and suffer injury or death, the FDA said. The agency said it hasn't received any such reports.
Diabetics who purchased the counterfeit test strips should stop using them, replace them immediately and call a doctor, the FDA said.
The counterfeits are:
OneTouch Basic/Profile, lot numbers 272894A, 2619932 and 2606340. The 50-count packages are labeled in English and French.
OneTouch Ultra, lot number 2691191. The 50-count packages are labeled in English, Greek and Portuguese.
Samples of the stripes tested by LifeScan do produce blood-glucose results, but they do not meet company specifications, LifeScan spokesman Dave Detmers said.
The FDA is investigating, an agency spokeswoman said. Neither the FDA nor the company could say how many of the counterfeits were sold. Detmers said the company had received a few dozen reports of fakes, primarily from consumers.
The fakes were distributed nationwide but primarily in Ohio, New York, Florida, Maryland and Missouri by Medical Plastic Devices Inc., of Quebec, Canada, and Champion Sales Inc., of Brooklyn, N.Y., the FDA said.
LifeScan said it was "vigorously pursuing legal actions." Detmers would only say that the company had two civil suits pending, and he declined to provide details.
A message left with Medical Plastic Devices was not immediately returned. No listing for a Champion Sales in Brooklyn could be found.
The alert came a day after LifeScan said it was voluntarily recalling one lot of its SureStep Pro test strips (lot number 2634187008) and a single lot of its OneTouch SureStep test strips (lot number 2627353). The lots contain some test strips that don't give proper confirmation readings, the company said.
Consumers with questions can call LifeScan at (866) 621-4855.