DRUG RECALL - FreeStyle Blood Glucose Meter and FreeStyle Flash Blood Glucose Meter (used to test blood glucose levels in Diabetics)
On March 14, 2014, Abbott issued a voluntary recall of FreeStyle Blood Glucose Meters and FreeStyle Flash Blood Glucose Meters which are used for testing blood glucose levels in diabetes patients.
The recalled FreeStyle Blood Glucose Meters and FreeStyle Flash Blood Glucose Meters are displaying glucose results that are incorrectly low when used with the Abbott FreeStyle test strips.
If you have either of these recalled blood glucose meters you should contact Abbott Diabetes Care at 1-888-345-5364 to request a replacement meter immediately. If you have an alternative meter you should begin to use the alternative meter to conduct your testing until the replacement arrives.
If you do not have an alternative blood glucose meter, continue to test your blood glucose levels following your doctor’s instructions using the recalled meter while taking the following precautions until you receive the replacement meter.
1) Confirm the meter is working correctly by conducting a quality control solution test and do not use the test strip vial if the results are not within the expected range.
2) If your test results are not within the range of your normal test results or you don’t feel as though your blood glucose levels are testing accurately, do not use the meter
3) If you are not feeling well or are experiencing symptoms of high blood glucose levels call your doctor immediately. Symptoms of high blood glucose levels may include excessive thirst, frequent urination, blurred vision, weakness, nausea, vomiting, and abdominal pain
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.
If you have any questions about this recall please contact your local retail pharmacist or speak to your doctor.
Adverse events that may be related to the use of this product may also be reported to the United States Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax:
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail the form to: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787