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FDA > CDRH > Medical Device Recalls > Class I Recall: Abbott Blood Glucose Meters

Medical Device Recalls
Class I Recall: Abbott Blood Glucose Meters

Date Recall
Initiated
 June 7, 2005
Product:
 Abbott Diabetes Care, Inc. Blood Glucose Meters with the following models and lot numbers:
  • FreeStyle FLASH Blood Glucose Monitoring System - All lot numbers beginning with R and all lot numbers T-G158-62981 and below.
  • Tracker Blood Glucose Monitoring System - All lot numbers beginning with E.
  • Xceed Blood Glucose Monitoring System - All lot numbers beginning with XC0999 and below.
  • ReliOn Ultima Glucose Monitoring System - All lot numbers.
  • Kroger Glucose Monitoring System - All lot numbers.
  • RiteAid Glucose Monitoring System - All lot numbers.
  • Liberty Glucose Monitoring System - All lot numbers.
  • Boots Glucose Monitoring System - All lot numbers.
  • Optium Glucose Monitoring System - All lot numbers.
  • Xtra Classic Glucose Monitoring System - All lot numbers.
  • Easy Glucose Monitoring System - All lot numbers.
  • SofTrac Glucose Monitoring System - All lot numbers.
  • FreeStyle Glucose Monitoring System - All lot numbers beginning with A, B, C, D, G, H, K, and M. All lot numbers from V-G157-31584 and below are included ***except for the following***: V-G156-31274, V-G15631455, V-G156-31983, , V-G156-32232, V-G156-32395, V-G156-32417, V-G156-32458, V-G156-32538, V-G157-30069, V-G157-30113, V-G157-30127, V-G157-30167, V-G157-30180, V-G157-30182, V-G157-30206, V-G157-30218, V-G157-30222, V-G157-30230, V-G157-30258, V-G157-30260, V-G157-30351, V-G157-30419, V-G157-30430, V-G157-30436, V-G157-30472, V-G157-30475, V-G157-30514, V-G157-30585, V-G157-30614, V-G157-330618, V-G157-30636, V-G157-30681, V-G157-30700, V-G157-30730, V-G157-30767, V-G157-30818, V-G157-30828, V-G157-30859, V-G157-30898, V-G157-30901, V-G157-30916, V-G157-30923, V-G157-30960, V-G157-30977, V-G157-31039, V-G157-31076, V-G157-31129, V-G157-31147. All lot numbers Y-G018-32983 and below are included.
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:
  • Consumers using Abbott Diabetes Care blood glucose meters may continue to safely use their meters and should verify that their meter is displaying the correct unit of measure each time they test. For information on how to change the unit back to mg/dl users should refer to the device Owner’s Manual or contact Abbott.
  • If a recalled meter cannot be reset to the correct unit of measure, consumers may contact Abbott Diabetes Care at 1-800-553-4105 (open 24 hours) to request a replacement.
  • If consumers have health concerns because of long term reading of the wrong unit of measures on their meter, they should contact their doctors.

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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