Company: Abbott Diabetes Care, Inc..
Date of Enforcement Report: 6/7/05
Class:I
PRODUCT
Abbott Diabetes Care, Inc. Blood Glucose Meters
REASON
The recalled Abbott blood glucose meters 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).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc.,1360 S Loop Road,Alameda, CA 94502-7000.
Manufacturer: Abbott Diabetes Care, Inc.
