GenStrip Blood Glucose Test Strips May Give False Results, FDA Warns

Federal regulators warn that GenStrip blood glucose test strips may give users the wrong results when used with the LifeScan One Touch glucose meters, putting them at risk of making diabetes dietary and treatment decisions that could cause adverse health consequences.  

Shasta’s GenStrips blood glucose test strips should not be used, the FDA told consumers on Tuesday. The agency also warned the manufacturer that it failed to meet required quality control standards.

In an FDA safety communication issued on April 29, the FDA told diabetics, doctors and distributors to stop using, selling and distributing GenStrip test strips. The strips are designed to be used for patients with type I and type II diabetes to measure their blood glucose levels with the LifeScan OneTouch glucose meters. The Shasta Genstrips are not made by the same company as the LifeScan OneTouch glucose meter, and the FDA’s warnings do not involve the meter itself.

Patients with diabetes rely on the test strips to give accurate readings, so that they may adjust their insulin levels accordingly. In the event patients are provided by false readings, it may cause them to delay treatment, which could cause hypoglycemia or for them to over-treat potentially causing hyperglycemia.

On April 8, the FDA sent a warning letter to Shasta Technologies, LLC, informing the company they were in violation of multiple federal regulations and quality control requirements. The warning letter indicated company did not have a sufficient adverse event reporting system, customer complaint systems, or a system for implementing corrective and preventive action.

Additionally, the letter stated that the company failed to meet product quality requirements, failed to maintain control of necessary documents, and failed to maintain procedures to control the design of the device to ensure specified design requirements are met.

The recalled GenStrip blood glucose test strips were manufactured by Shasta’s Technologies, LLC, and have been distributed for sale to the public, healthcare providers, pharmacies, and hospital supply managers both online and through retail pharmacies since March 2013.

To date, Shasta’s Technologies has been unwilling to recall the products, but the FDA stated in the warning letter to Shasta Technologies that if the violations are not corrected promptly then regulatory actions such as seizure, injunctions, and/or civil penalties will be pressed against them.

The FDA has cleared other third-party test strips to be used for the LifeScan OneTouch blood glucose meters but urges users to discontinue the use of the GenStrip test strips.