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FreeStyle® and FreeStyle Flash® Blood Glucose Meters Recalled

Abbott Diabetes Care Recall

Abbott Diabetes Care is conducting a voluntary recall of the FreeStyle® Blood Glucose Meter and FreeStyle Flash® Blood Glucose Meter. Both blood glucose meters have not been in production since 2010. These meters are being recalled because they may produce mistakenly low blood glucose results. In an Abbott press release dated March 14, 2014, it was stated, "Other Abbott Diabetes Care meters are not affected by the recall."

Although Abbott started to notify users on February 19, 2014, both Abbott and the U.S. Federal Drug Administration issued a new recall notice on March 14, 2014.

Abbott recommends people who use either the FreeStyle® and/or FreeStyle Flash® Blood Glucose Monitors do the following:

  • 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 healthcare professional immediately.

For more information, please visit www.abbottdiabetescare.com/press-room.

Source
Recall -- Firm Press Release. March 14, 2014. Abbott Issues Recall of Certain Blood Glucose Monitoring Systems. http://www.fda.gov/Safety/Recalls/ucm389357.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 17, 2014.

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