GenStrip blood glucose monitoring test strips unreliable, FDA reports

Patients with diabetes and health care professionals should stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels, according to a Safety Communication released by the FDA.

The strips sold by Shasta Technologies LLC are “third party” and not made by the same company as the meter with which they are used, according to the communication. Available for use in homes and health care facilities, GenStrips are promoted for use with the LifeScan OneTouch family of glucose meters, including Ultra, Ultra 2 and Ultra Mini.

The affected strips, which may be identified by their green and white packaging and name, have been manufactured and distributed since March 2013 and are available through online retailers and retail pharmacies. The FDA recommends alternative glucose test strips designed for use with the LifeScan OneTouch family of glucose meters be used in light of this notice.

The FDA in early April sent a warning letter to Shasta for violations of federal quality systems regulations, which require manufacturers establish and document procedures to assure quality, following an inspection early in the year. The regulations include ways to deal with customer complaints, adverse event reports and purchasing from suppliers, as well as investigating and correcting manufacturing problems.

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

To date, the company has not voluntarily recalled the test strips. The FDA recommends patients and health care providers discontinue use of Shasta Technologies, LLC GenStrip Test Strips, and retailers and distributors discontinue sale and distribution and remove unsold product from shelves.

For more information: FDA Safety Communication