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Recall of Defective Glucose Test Strips

FDA Says Faulty Strips Could Give Diabetes Patients Inaccurate Reading of Glucose Levels

Which Strips Are Being Recalled continued...

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:

  1. 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.
  2. 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.

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