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FDA Warning for GenStrip Blood-Sugar Test Strips

FDA Warning for GenStrip Blood-Sugar Test Strips

April 30, 2014 — GenStrip Blood Glucose Test Strips should not be used because they can potentially report false results, according to a Drug Safety Communication issued by the U.S. Food and Drug Administration (FDA).

The manufacturer, Shasta Technologies LLC, advertises GenStrip for use with the LifeScan OneTouch family of glucose meters (e.g., Ultra, Ultra 2, and Ultra Mini).

The problem is that FDA inspectors found “extensive violations of federal regulations” — Shasta did not have an adequate quality control system in place to ensure the accuracy of the blood-sugar test strips or respond to customer complaints about problems. The problems were described in a Warning Letter issued by the FDA on April 8. Despite the problem, Shasta Technologies has not voluntarily recalled GenStrip Test Strips.

For people with diabetes, the FDA recommends discontinuing use of GenStrip Blood Glucose Test Strips. You should buy another blood-sugar test strip compatible with the LifeScan OneTouch family of glucose meters. If you need help, talk to your pharmacist or diabetes care provider and ask which test strips to use.

Hypoglycemia and Hyperglycemia

Inaccurate test-strip readings can lead to an incorrect dosage of insulin. Complications may include hyperglycemia (high blood sugar) and hypoglycemia (hypoglycemia). The FDA recommends:

“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.”

Hyperglycemia symptoms:

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

Hypoglycemia symptoms:

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

Do I have a GenStrip Blood-Sugar Test Strip Lawsuit?

The Schmidt Firm, PLLC is currently accepting GenStrip Blood-Sugar Test Strip induced injury cases in all 50 states. If you or somebody you know has been injured by complications of hyperglycemia or hypoglycemia, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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