FDA Recalls Diabetes Test Strips

According to the American Diabetes Association, nearly 26 million people in the U.S. have diabetes. Of those who have been diagnosed, many understand the need to test their blood sugar (glucose) regularly, and do so using a variety of home tests.

The website of Nova Diabetes, Inc., which makes a variety of products geared to the diabetes market, claims to have the “best overall glucose monitors,” but a recent warning issued by the FDA calls that claim into serious question.

The feds’ warning accompanied a voluntary recall of as many as 62 million glucose test strips manufactured by Nova Diabetes Care because they can show incorrect readings that reflect abnormally high blood sugar. Such results can prompt patients to take dangerous amounts of medication.

The strips included in the recall are in certain lots of Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits distributed in the U.S., Canada, Chile, Peru, Argentina, the Dominican Republic, Jamaica and a half-dozen other countries. They’re sold in retail stores as well as online.

The FDA warning says that the strips are contaminated with a chemical used in the manufacturing process that corrupts the readings.

In the FDA alert, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said, “It is important that patients using these test strips discontinue their use immediately. A false reading could result in patient harm and delay critical care.”

To find out if you have any of blood glucose test strips in the affected lots, link to the Nova Diabetes Care recall page. You may also call customer service at (800) 681-7390. If you own any of the contaminated strips, you’ll be directed to return them for replacements at no charge.

In the meantime, according to the FDA:

  • Immediately discontinue use of the recalled strips and take the necessary steps to continue to monitor your blood sugar.
  • 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 the only test strips available to you are from affected lots, continue testing your blood glucose. But to reduce the chance of a false reading:

  • As stated in the Blood Glucose Monitor Owners Guide and Nova Max Glucose Test Strip Product Insert, perform a quality control solution test to confirm that your vial of Nova Max Glucose Test Strips is working correctly. Do not use a test strip vial if control solution results are not within the expected range.
  • Verify all elevated blood glucose test results that are not consistent with your diabetes history by repeating the test using a new blood glucose test strip from a different vial (if available) or the same vial (if a new vial is unavailable).
  • Contact your doctor immediately if your reported blood glucose result(s) are not consistent with your diabetes history, how you feel or if you think your results are not accurate (higher than expected).

In addition, pay special attention to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). Don’t ignore symptoms or make significant changes to your diabetes management program without speaking to your doctor.

Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.

Symptoms of low blood sugar may include trembling, excessive sweating, weakness, hunger, confusion and headache. Some people might not have symptoms before they develop unconsciousness or seizures. Treat low blood sugars promptly to avoid loss of consciousness or a seizure.

For information about diabetes and malpractice, see our backgrounder.

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