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Medical Devices / Regulatory Affairs / Postmarket Safety

FDA: GenStrip Blood Glucose Test Strips May Give False Readings

May 1, 2014

The FDA Tuesday warned healthcare professionals and patients with Types I and II diabetes to stop using Shasta Technologies’ GenStrip blood glucose test strips due to the risk of inaccurate results. The alert follows a Dec. 2-9 inspection of Shasta’s Sherwood, Ore., facility that turned up numerous quality system violations.

An Apr. 8 warning letter cited 11 violations of good manufacturing practices, including lack of evidence of robust and efficient corrective and preventive action procedures, inadequate complaint handling and design control procedures, and insufficient qualification of suppliers. The letter was posted the FDA’s website on Tuesday.

“Without an assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels,” the safety communication says.

The agency recommends that patients and providers purchase alternate test strips compatible with the LifeScan OneTouch meters and urges retailers to stop selling the GenStrip test strips. — Lena Freund

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