FDA Warns Against the Use of GenStrip Test Strips
The U.S. Food and Drug Administration is advising that patients not use GenStrip blood glucose test strips sold by Shasta Technologies LLC.
Strips May Give Incorrect Readings
“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.” – FDA release as published by Medscape
According to Medscape, the FDA is warning customers that Shasta’s GenStrip blood glucose monitoring strips may give inaccurate blood glucose readings and should not be used.
The strips are a third-party product and made for the LifeScan OneTouch family of glucose meters, including the Ultra, Ultra 2 and Ultra Mini. Affected strips were manufactured and distributed beginning March 2013 and are available through retail pharmacies and online retailers.
The strips are most often packaged in white and green packaging with the GenStrip name on top.
The FDA is recommending that patients use alternative blood glucose test strips in place of the GenStrip products.
Shasta Refuses to Recall Strips Despite Extensive Violations
During a recent inspection of Shasta Technologies LLC, the FDA observed “extensive violations” of federal regulations put in place to ensure the quality of products. A warning letter was addressed to the company on April 8.
Shasta, however, has remained unwilling to recall the test strips, resulting in the products remaining on the market and available to consumers. As a result, the FDA has decided to intervene and recommend that distributors and retailers no longer sale or distribute the GenStrip glucose strips.
Consumers who experience adverse reactions or quality control problems are advised to report such occurrences to MedWatch.