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Blood Testing Strips May Be Inaccurate

December 29, 2004
Pennsylvania Attorney General Jerry Pappert is warning consumers not to rely on the results of certain glucose blood testing strips sold in pacakges that state the products are not intended for use or sale in the United States. The strips produced by Roche Diagnostics may cause serious health problems, particularly to diabetics, by providing inaccurate blood sugar level readings.

Pappert urged consumers to immediately stop using all glucose blood testing strips from Accu-Chek Sensor Comfort and Accu-Chek Advantage II that contain any of the following markings on the box: "Made in USA for Export Only" "For Sale Outside of the USA and Canada" "For Export Only"

In addition, all Accu-Chek test strips with six digit lot numbers beginning with lot #44 are for exportation only and are not to be used in the United States. Consumers should also discontinue using any other blood test strip product that contains similar "export only" language and consult their doctor.

The warning follows concerns by the product manufacturer that the strips may have been repackaged and reimported into the United States. According to the manufacturer, the alleged counterfeit products are NOT approved or cleared for use in the U.S. by the U.S. Food and Drug Administration.

Pappert said consumers who use these products should check both the outside packaging for the "export only" label, and the lot number on the strip holder inside the box. The lot number should appear on the outside of the box and also on the plastic strip holders and computer chip inside the box. Failure to inspect these products could be dangerous and result in a false blood sugar reading that may significantly affect the proper treatment for diabetes or other illnesses.

Glucose strips sold outside of the U.S. are programmed to test whole blood and not blood plasma as required in this country. As a result, these strips are calibrated differently than test strips sold in the United States and will provide a significantly different reading. According to the manufacturer, the glucose readings could deviate by as much as 12 percent. These inaccurate readings pose potential harm to those required to regularly monitor their blood sugar levels.

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