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The U.S. Food and Drug Administration claims that the Johnson & Johnson company is failing to adequately warn the public about the dangers of using certain defective SureStep blood glucose meters. As reported in DIABETES HEALTH (see "290,000 SureStep Meters Recalled," July 1998, p. 10), J&J recently began recalling its SureStep meters sold before August 1997. The monitors failed to measure blood sugar levels in excess of 500 mg/dl. At such levels, the meters display an "ER 1" error message instead of the glucose concentrations.
"LifeScan has characterized this as a product replacement program," said the FDA in a prepared statement. "However, FDA is concerned that some diabetics, wholesalers and distributors who purchased these meters may be misled and not realize this product replacement is for a potentially serious malfunction."
Two individuals with serious diabetes died after having used a faulty meter, because they did not know their blood sugars were dangerously high.
Because of the risk of death, the FDA considers the recall a Class 1 recall. The agency advises patients who use SureStep monitors to beware of an "Er-1" message, which can mean a very high level of blood sugar.
SureStep meters with serial numbers beginning with L6000 XX XXXXX through L7205 XX XXXXX are the units being replaced. Units with serial numbers L7206 XX XXXXX and higher are not being replaced.
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