GenStrip Blood-Sugar Test Strips May Report False Results

April 30, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication to warn about the risk of incorrect results from GenStrip Blood Glucose Test Strips, which are manufactured by Shasta Technologies LLC.

According to the FDA, a recent inspection found that Shasta did not have an adequate quality control system in place. They found “extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips,” including a failure to address complaints. These problems were documented in a Warning Letter issued April 8.

FDA Recommendation for People with Diabetes

• Discontinue use of GenStrip Blood Glucose Test Strips.
• Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
• 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 high or low blood sugar, contact your diabetes care provider for advice on treatment.

Symptoms of Hyperglycemia (High Blood-Sugar)

• Increased thirst and urination
• Breath smells sweet
• Fatigue
• Agitation
• Confusion

Symptoms of Hypoglycemia (Low Blood Sugar)

• Cold, clammy skin
• Trembling
• Lack of motor coordination
• Fatigue
• Irritability or confusion
• Blurred vision, headache, dizziness
• Nausea or stomach pain
• Fainting

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