Millions of Diabetes Glucose Test Strips Recalled

December 26, 2010

Abbott Diabetes Care, a division of Abbott Laboratories, is voluntarily recalling 359 million test strips used by diabetics to monitor blood glucose levels.

According to the U.S Food and Drug Administration (FDA) release, these recalled test strips may give falsely low blood glucose results. The low readings may cause the user to take action to raise the blood glucose or fail to treat high blood glucose levels.

The following brands of test strips are affected:

Precision Xtra Blood Glucose Test Strips

Precision Xceed Pro Blood Glucose Test Strips

Precision Point of Care Blood Glucose Test Strips

Medisense Optium Blood Glucose Test Strips

Relion Ultima Blood Glucose Test Strips

Optium Blood Glucose Test Strips

OptiumEZ Blood Glucose Test Strips

Consumers should check their products to the complete list of products and lot numbers.

“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.”

Consumers with these test strips should stop using them and switch to an alternate testing method or purchase unaffected test strips if available. Those people who have neither should not stop testing their blood glucose, but continue to do so with these precautions:

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.

Healthcare facilities should also stop using these test strips and switch to unaffected lots or another testing method. If these alternatives are not available in the facility, the FDA says they should:

1. Verify any critical glucose test results (e.g., test results that may be used to adjust insulin therapy in vulnerable patient populations) generated on the Precision Xceed Pro Blood Glucose Test System using a central laboratory blood glucose method. Medical judgment should be applied when deciding whether to act on results prior to verification.
2. Verify any Precision Xceed Pro Blood Glucose Test System results that do not match a patient’s symptoms, or seem unexpected for the patient’s clinical status, using a central laboratory blood glucose method.
3. When using the Precision Xceed Pro Blood Glucose Test System, take precautions to reduce the chance of an erroneous reading. Limited evidence suggests that results may be accurate using strips from affected lots if fill time does not exceed five seconds. Monitor the amount of time it takes for the Precision Xceed Blood Glucose Meter to start the “countdown” after blood is first applied to the test strip. If the amount of time exceeds five (5) seconds, discard that test strip immediately because the blood glucose result may be erroneously low. In addition, if this occurs:
   i. Note the specific lot number of that test strip;
   ii. Notify Abbott Diabetes Care to report the observed problem with that lot by calling 1-877-529-7185;
   iii. Make sure to check fill time on each individual strip during use and do not assume if one strip in a package/lot appears to be unaffected, that all strips in that package/lot are unaffected.

Abbot will replace the recalled product free of charge. However, it may take up to two weeks for delivery.

Consumers can visit the Abbott Diabetes Care recall website or call customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español) for more information and instructions for returning the recalled test strips.