March 17, 2014
Abbott Issues Recall of Certain Blood Glucose Monitoring Systems
The Missouri Department of Health and Senior Services received information regarding a recall of FreeStyle® Blood Glucose Meters and the FreeStyle Flash® Blood Glucose Meters.
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. 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 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.
- 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, take the following precautions to reduce the chance of a false reading:
- As stated in the product insert, perform a quality control solution test to confirm that your meter is working correctly. Do not use a test strip vial if control solution results are not within the expected range.
- Contact your health care provider immediately if your blood glucose result(s) are not consistent with your diabetes history, how you feel, or if you think your results are not accurate (higher or lower than expected). Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately.
This voluntary recall does not apply to any other Freestyle brand blood glucose monitoring systems - Freestyle Lite®, Freestyle Freedom Lite® or Freestyle InsuLinx® systems can continue to be used with the Freestyle test strips. For users of the OmniPod® Insulin Management System with the built-in FreeStyle Blood Glucose Meter, please refer to the previously sent letter for Abbott recommended actions or visit www.abbottdiabetescare.com/press-room/2014/2014-b.html.
The full recall can be found at www.fda.gov/Safety/Recalls/ucm389357.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.