FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results
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. See the Recall Notice for detailed instructions for providers and patients, and see links to additional resources below.
AUDIENCE: Consumer, Pharmacy
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.
- Abbott Diabetes Care Press Release
- Abbott Diabetes Care Notification Important: Urgent Product RECALL FreeStyle and FreeStyle Flash Blood Glucose Monitoring System
- Abbott Diabetes Care Notification Important: Urgent Product RECALL FreeStyle blood glucose meter built into the OmniPod Personal Diabetes Manager
- Additional Information for FreeStyle Blood Glucose Meters Built into the OmniPod Insulin Management System