FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results

April 14, 2014

Audience: Consumer, Pharmacy

including the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter

 

UPDATED 04/14/2014. FDA classified this product recall as Class I.

 

[Posted 03/16/2014]

ISSUE: Abbott is conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results.

BACKGROUND: FreeStyle and FreeStyle Flash Blood Glucose Meters have not been in production since 2010. Abbott began notifying users on Feb. 19, 2014, immediately after the issue was discovered.

RECOMMENDATION: Abbott recommends the following actions for people with meters affected by this recall:

  • Immediately contact Abbott Diabetes Care at 1-888-345-5364 to obtain a replacement meter.
  • If the only meter available to you is an affected meter, continue to test your blood glucose as recommend by your doctor while you wait for your replacement meter. When using an affected meter, follow the precautions and recommendations in the press release. 
  • If you have access to an alternative glucose meter, immediately discontinue use of the affected meter and take the necessary steps to continue to monitor your blood sugar with the alternative meter.
  • For users of the OmniPod Insulin Management System with the built-in FreeStyle Blood Glucose Meter, refer to the Abbott recommended actions at https://www.abbottdiabetescare.com/press-room/2014/2014-b.html .

See the press release for additional information and recommendations.


 

[04/14/2014 - Recall Notice - FDA]
[03/16/2014 - Press Release - Abbott]

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