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U.S. Department of Health and Human Services

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Abbott Diabetes Care Blood Glucose Meters

Audience: All healthcare professionals and consumers

[UPDATE 11/04/2005] Class I recall posted.

[Posted 10/27/2005] FDA notified health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA.

[November 04, 2005 - Recall Notice - FDA]
[October 26, 2005 - News Release - FDA]

Previous Related MedWatch alerts:

May 17, 2005 - LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters