The FDA has advised people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. The FDA’s recent inspection found many violations of federal regulations intended to assure quality in the manufacturing of GenStrip Test Strips. The failure to have an adequate quality system in place caused the FDA to believe that the strips could report incorrect blood glucose levels.
GenStrip Blood Glucose Test Strips are what are called “third-party” blood glucose monitoring test strips. in that they are made by another manufacturer thank who makes the blood glucose meter they are to be used in, LifeScan OneTouch’s family of glucose meters (Ultra, Ultra 2 and Ultra Mini).
The FDA recommends that you discontinue using GenStrip Blood Glucose Test Strips and instead use alternative glucose test strips that are designed for use with your glucose meter.
More information is available here.
