Medical Devices

Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) - Erroneously Low Blood Glucose Results

Recall Class: Class I

Date Recall Initiated: February 19, 2014

Products: FreeStyle and FreeStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM)

Use: The FreeStyle and FreeStyle Flash Blood Glucose Meters measure sugar (glucose) levels in blood samples of people with diabetes.

FreeStyle and FreeStyle Flash Blood Glucose Meters are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Additionally, the OmniPod Personal Diabetes Manager system contains an integrated FreeStyle meter.

Recalling Firm:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502

Reason for Recall: Abbott Diabetes Care has identified that certain meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips. This issue occurs with FreeStyle, FreeStyle Flash Blood Glucose meters and the FreeStyle blood glucose meter built into the OmniPod Insulin Management System. Affected meters and test strips have been identified by Abbott and customer notification letters with specific instructions for each product have been issued.

Abbott Diabetes Care is requesting users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue use of these meters and to call Abbott for a new unaffected meter.

Users of the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager are requested to discontinue use of affected test strips and to call Abbott for replacement unaffected test strips.

The use of affected product may cause serious adverse health consequences, including death.

Public Contact: For questions about this recall, contact Abbott Diabetes Care Customer Service at 1-877-584-5159 or 1-888-345-5364.

FDA District: San Francisco District Office

More Information About This Recall:

Consumers and health care professionals who are using the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager should take the following steps:

  • Discontinue use of any FreeStyle Blood Glucose Test Strips you may have until you obtain replacement strips from Abbott Diabetes Care. To receive replacement strips at no cost contact Abbott Diabetes Care Customer Service at 1-877-584-5159.
  • Continue using your OmniPod Insulin Management System (OmniPod) to deliver your insulin therapy. While waiting for your replacement strips to arrive, use the FreeStyle Freedom blood glucose meter that you may have previously received with your welcome pack. FreeStyle test strips when used with the FreeStyle Freedom blood glucose meter will produce accurate blood glucose results.
  • If you would like to continue using the OmniPod system to recommend dosing, follow your OmniPod Insulin Management System instructions for manually entering blood glucose readings.
  • Use control solutions to check the performance of your test strips and meter until you receive your replacement test strips. If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider immediately.
  • Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms of high blood sugar may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.

Consumers and health care professionals who are using the FreeStyle Flash or FreeStyle Blood Glucose Meter should take the following steps:

  • Discontinue use of your FreeStyle Flash or FreeStyle Blood Glucose Meter and call Abbott Diabetes Care Customer Service at 1-888-345-5364. When you call, Abbott will send you a new FreeStyle branded meter at no charge.
  • If the only meter you have available is a FreeStyle or FreeStyle Flash Blood Glucose Meter, do not stop testing your blood glucose. Control solution should be used to check the performance of your test strips and meter until you receive your replacement meter. However, if any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.
  • Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms of high blood sugar may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
  • Upon receiving your new replacement meter, please immediately dispose of your old meter in accordance with your local and state disposal regulations.

On February 14, 2014, Abbott Diabetes Care sent an Important: Urgent Product RECALL disclaimer icon  letter to customers using the FreeStyle Blood Glucose meter built into the OmniPod Insulin Management System. disclaimer icon The customers were instructed to discontinue use of FreeStyle test strips, and call Abbott Diabetes Care Customer Service at 1-877-584-5159 for replacement test strips at no charge.

The firm sent another Important: Urgent Product RECALL disclaimer icon  letter, on February 19, 2014 to all customers using FreeStyle and FreeStyle Flash Blood Glucose Meters. Abbott also issued a press release disclaimer icon  on March 14, 2014. The letter describes the product, the problem, and actions to be taken. Customers were instructed to discontinue use of their FreeStyle Flash or FreeStyle Blood Glucose Meter disclaimer icon  and to call Abbott Diabetes Care Customer Service at 1-888-345-5364 for replacement meters at no charge. Upon receiving replacement meters customers were instructed to immediately dispose of their old meter in accordance with local and state disposal regulations.

About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 06/03/2014
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