FDA Recommends All Diabetes Patients Stop Using GenStrip Test Strips

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication directed at all type 1 and type 2 diabetes patients who monitor their blood glucose levels.

The FDA is recommending that all diabetes patients who use GenStrip Blood Glucose Test Strips to discontinue using them because the FDA has reason to believe the strips are reporting incorrect blood glucose levels.

GenStrip test strips are sold by Shasta Technologies. They are so-called "third-party" blood glucose monitoring test strips, meaning they aren't test strips made by the same company that made the meter with which they're used. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g., Ultra, Ultra 2 and Ultra Mini).

Violation of Federal Regulations

Recently, the FDA conducted an inspection of Shasta Technologies, finding "extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips."

These regulations, called quality systems regulations, "require manufacturers to establish and document procedures that assure quality ... and require manufacturers to establish and document procedures for assuring the quality of manufactured product, and for investigating and correcting manufacturing problems."

The FDA determined that Shasta didn't have many of those in place. Lacking them, the FDA "believes that the strips could report incorrect blood glucose levels."

While the test strips should no longer be available on the market, the company has at this point been unwilling to voluntarily recall them.

The FDA has cleared other glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters, and the agency urges customers to use these alternatives with their LifeScan OneTouch glucose meters.

What to Do

The U.S. FDA is recommending that all type 1 and type 2 patients do the following:

1. Identify whether you use GenStrips glucose test strips (which may be packaged in a green and white box with the GenStrip name on top).
2. If yes, discontinue use of GenStrip Blood Glucose Test Strips.
3. Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
4. Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.

As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either, contact your diabetes care provider for advice on treatment.

Source: FDA