The FDA is advising healthcare professionals and patients to stop using GenStrip Blood Glucose Test Strips (Shasta Technologies) because the strips may report false blood glucose levels.
A recent FDA inspection found extensive violations of federal quality system regulations in the manufacturing of GenStrip Test Strips. Shasta Technologies did not have many of the requirements of a quality system in place. The FDA believes that the strips may report incorrect blood glucose levels, which may place the patient at risk of hyperglycemia or hypoglycemia.
The affected strips were manufactured and distributed since March 2013 through online retailers and pharmacies. The strips may be packaged in green and white packaging with the GenStrip name on top.
The GenStrip Test Strips are marketed for use with the LifeScan OneTouch family of glucose meters, including OneTouch Ultra, OneTouch Ultra2, and OneTouch UltraMini. The FDA recommends users to stop using GenStrip Blood Glucose Test Strips and to obtain alternative strips that are compatible with the LifeScan OneTouch glucose meter line.
For more information call (855) 436-7877 or visit FDA.gov.