290,000 SureStep Meters Recalled

| Jul 1, 1998

Johnson & Johnson's LifeScan is voluntarily recalling and replacing its SureStep glucose meters sold before August 1997. The monitors failed to measure high blood sugar levels in excess of 500 mg/dl. At such levels the meters display an, "ER 1" error message instead of the glucose concentration. The problem, which is software related and not in the machine itself, does not exist in units sold after August 1997.

Despite the recall, "patients should continue to test their blood glucose. If they get an error message with the SureStep Consumer Meter, patients should be aware that they may have very high blood glucose," says LifeScan.

Because of the malfunction, LifeScan is advising users to compare the blue dot on the test strip with the color chart on the test strip bottle. If the dot on the strip is darker than the darkest oval on the bottle's color chart, the user likely has a very high BG level and should call his health care professional immediately.

To identify a SureStep meter manufactured before August 1997, look for the serial number on the back of the meter. Units that have serial numbers beginning with L6000 XX XXXXX through L7205 XX XXXXX are the units that will be replaced. Units with serial numbers L7206 XX XXXXX and higher are not being replaced.

All users of SureStep meters with the above serial numbers, and those with any other questions should call LifeScan's special 24-hour customer service line at (800) 951-7226.

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Categories: Blood Glucose, Blood Sugar, Meters


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