FDA Warns That GenStrip Blood Glucose Test Strips May Report False Results

The FDA is advising patients to stop using GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, because the strips may report incorrect blood glucose levels.  The GenStrips are sold for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini).  According to the FDA Safety Communication, "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."  Read more Diabetes Treatment Alerts.

[1] FDA, "GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results," April 29, 2014.