Abbott Diabetes Care is recalling 359 different lots of
glucose test strips marketed under the following brand names:
- Precision Xceed Pro;
- Precision Xtra;
- Medisense Optium;
- Optium;
- OptiumEZ; and
- ReliOn Ultima.
These strips are used with Abbott's Precision Xtra,
Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima
blood glucose monitoring systems. As many as 359 million strips may be affected
by the recall. The blood glucose monitoring systems are not affected by this
recall.
The recall pertains to certain lots of these test strips
distributed in the United States and Puerto Rico. Other Abbott Diabetes Care
products are not affected by the recall.
False lows
The test strips being recalled may give falsely low blood
glucose results. Such results may lead patients to try to raise their blood
glucose unnecessarily, or they may fail to treat elevated blood glucose because
of a false, low reading. Both scenarios
pose risks to a patient's health.
The recall is related to the test strips' inability to
absorb enough blood for monitoring. Strips exposed to warm weather or prolonged
storage may be more likely to provide a false result.
The test strips were manufactured between January and May
2010 and are sold both in retail and online settings directly to consumers, but
are also used in health care facilities.
How you know
The Food and Drug Administration (FDA)
has provided recommendations for consumers and health care professionals below
that explain how to determine whether a particular lot is affected, how to
order free replacement strips and how to use recalled strips to reduce the
likelihood a false result.
"Patients with diabetes should be aware of the recalled
glucose test strips and take steps to prevent them from affecting their
health," said Alberto Gutierrez, Ph.D., director for the Office of In
Vitro Diagnostics in FDA's Center for Devices and Radiological Health. "FDA and Abbott are reviewing the cause of the manufacturing defect to
avoid this problem in the future."
To determine if you have a product being recalled, call
Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010
(Spanish) to speak with a customer service representative or visit this Website to look up test strip lot numbers.
Consumers should report serious adverse events (side
effects) with the device to the FDA's MedWatch Adverse Event Reporting program
either online, by
regular mail, using postage-paid, pre-addressed Form FDA 3500 and mailing it to the address on the pre-addressed form, by fax: 800-FDA-0178
or phone: 800-332-1088.
Recommendation
For consumers who purchased test strips in retail stories or
online, 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:
- Precaution 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 that 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.
- Precaution 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.
- Pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).
- 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
- Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals 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.
