Date Recall Initiated |
June 7, 2005 |
---|---|
Product: |
Abbott Diabetes Care, Inc. Blood Glucose Meters with the
following models and lot numbers:
|
Use: |
Blood glucose meters are used by diabetes patients to measure the amount of glucose in their blood, and as an aid in monitoring the effectiveness of diabetes management in the home or clinical setting. |
Recalling Firm: |
Abbott Diabetes Care, Inc. 1360 S Loop Road Alameda, CA 94502-7000 |
Reason for Recall: |
The recalled Abbott blood glucose can inadvertently switch the glucose readings from mg/dL, the U.S. standard to mmol/L, the foreign standard. The unit of measure could change in the course of setting the time and date for the meters, when they are dropped or upon battery replacement. In the U.S., if the consumer does not realize that the units of measure changed from the U.S. standard to the foreign standard, misinterpretation of the test results could occur, potentially leading to hyperglycemia. Hyperglycemia is particularly harmful in pregnant women that could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies). |
Public Contact: |
Consumers with questions may call Abbott Diabetes Care at 1-800-553-4105 (open 24 hours). |
FDA District: |
San Francisco |
FDA Comment: |
Additional information about this recall is available for physicians and patients on the Abbott Diabetes Care Web site at http://www.abbottdiabetescare.com/news/20051014_urgentdevicecorrection.aspx Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. |
Updated November 4, 2005
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