Dec. 22, 2010 -- The FDA says it is working with Abbott Diabetes Care to recall 359 million defective glucose test strips -- sold under a variety of brand names -- that may make blood glucose levels look lower than they really are.
The FDA says the defective strips “can lead users to try to raise their blood glucose when it is unnecessary or to fail to treat elevated blood glucose due to a falsely low reading,” and that “both scenarios pose health risks.”
About 24 million Americans have diabetes.
Abbott says the defective strips aren’t absorbing enough blood to provide an accurate reading. The company also says test strips stored for a long time in medicine cabinets or test strips that have been exposed to warm temperatures could give false results.
“FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future,” Alberto Gutierrez, PhD, of FDA’s Center for Devices and Radiological Health, says in a news release.
Gutierrez says diabetes patients “should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health.”
Which Strips Are Being Recalled
The strips being recalled are used with Abbott’s MediSense Optium, Precision Xceed Pro, Precision Xtra, Optium, Optium EZ, and ReliOn Ultima blood glucose monitoring systems.
The lots were manufactured between January and May of this year and sold in retail stores in the U.S. and Puerto Rico. The strips are used both by consumers and health care professionals.
Abbott says the strips should not be used and will be replaced at no cost to consumers.
It says the monitoring systems themselves are not being recalled, just the defective strips.
Patients should contact their health care providers to determine testing options if they don’t have any unaffected test strips to use.
The FDA says it is working with Abbott to avoid any potential shortages of useable products. The company says it will take about eight weeks to produce and distribute enough strips to replace all the defective ones that have been distributed.
The FDA also says people with diabetes who want to find out if they have products that need to be returned should call Abbott Diabetes Care at 800-448-5234 for English speakers and at 800-709-7010 for Spanish speakers. The FDA says people wishing to look up test strip lot numbers should visit the web site www.precisionoptiuminfo.com.
In addition, consumers should report serious adverse side effects to the FDA by phone at 800-332-1088, fax at 800-FDA-0178, online at www.fda.govMedWatch/report.htm, or via regular mail at www.fda.gov/MedWatc/getforms.htm, where pre-addressed forms may be obtained.
Advice to Glucose Test Strip Users
Here’s what the FDA says people who purchased the test strips should do:
For people who purchased test strips in retail stories or online, the FDA recommends:
- Calling Abbott for a replacement of the affected strips. Abbott will send you unaffected Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips at no charge.
- While waiting for the replacement strips to arrive, use an alternate method to measure blood glucose (such as a different test system) or purchase at least two weeks' worth of new, unaffected strips while waiting for replacement strips.
- If you purchase Precision Xtra, Optium, OptiumEZ, and ReliOn Ultima Blood Glucose Test Strips in a store or online, check to be sure these are from unaffected lots. Ask a pharmacist to help you.
- If the only test strips available to you are from affected lots, do not stop testing your blood glucose.
But do take the following two precautions to reduce the chance of erroneous reading:
- Check the amount of time it takes for your blood glucose meter to start the "countdown" after you first apply blood to the test strip. Start timing immediately after blood first makes contact with the test strip. If your meter takes longer than five (5) seconds to start the countdown, test strip is defective and the result should not be used. Check the time for each test strip you use because all of the strips in a package may not be affected to the same degree.
- If any reading from a strip appears lower than you would expect or does not seem to match the way you are feeling, you should contact your health care provider.
- 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 provider immediately.
- Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some people may have no symptoms at all before they develop unconsciousness or seizures. It is important to treat low blood sugars promptly to avoid loss of consciousness or a seizure. If you are unable to obtain unaffected strips, you should contact your health care provider for advice on how to treat these symptoms before they occur.