Stop Using GenStrip Blood Glucose Test Strips, FDA Warns

Megan Brooks

Disclosures

April 29, 2014

GenStrip blood glucose test strips, sold by Shasta Technologies LLC, may give incorrect blood glucose readings and should not be used, the US Food and Drug Administration (FDA) warned today. This recall was issued after extensive quality control violations were found during a recent inspection of the company.

Shasta's GenStrip test strips are "third-party" blood glucose monitoring test strips not made by the same company as the meter with which they are used, the FDA noted in a safety communication.

These test strips are advertised for use with the LifeScan OneTouch family of glucose meters (eg, Ultra, Ultra 2, and Ultra Mini). The FDA recommends using alternative glucose test strips that are designed for use with the OneTouch family of glucose meters.

The affected test strips have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies. The strips may be packaged in green and white packaging with the GenStrip name on top.

"Extensive" Violations

A recent FDA inspection of Shasta Technologies LLC found "extensive violations" of federal regulations intended to ensure the quality of products in the manufacturing of GenStrip test strips, which the FDA outlined in an April 8 warning letter to the company.

"Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. An inaccurate blood glucose reading could lead to inappropriate or delayed treatment that could significantly harm a patient," the FDA said.

To date, the company has been unwilling to voluntarily recall their test strips, resulting in their continued availability, the FDA said. Therefore, the FDA is recommending the test strips not be used. The FDA is also asking distributors and retailers of the test strips to discontinue sale and distribution of GenStrip glucose test strips and to remove unsold products from shelves.

Adverse reactions or quality problems experienced with this product should be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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