AUDIENCE: Pharmacy, Risk Manager, Patient
ISSUE: The FDA is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.
During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels.
BACKGROUND: GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are "third-party" blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini).
RECOMMENDATION: Discontinue use of GenStrip Blood Glucose Test Strips. FDA recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
[04/29/2014 - Safety Communication - FDA]