The Food and Drug Administration recently issued a safety warning for consumers regarding the GenStrip blood glucose test strips manufactured by Shasta Technologies. The test strips are used by individuals with Type 2 Diabetes in conjunction with LifeScan OneTouch blood glucose meters to test the levels of sugar in their blood. If blood glucose levels get too high, a person has a high risk of developing acute hyperglycemia, a serious condition that often requires immediate medical attention and treatment. For this reason, the FDA strictly regulates the manufacture of testing materials to ensure blood glucose results are accurate.
Violations by Shasta Technologies
After recent inspections of Shasta Technologies, FDA investigators identified extensive violations, many regarding their quality assurance operations and procedures. The FDA sent a warning letter to the president of the company, identifying 11 separate violations of federal medical manufacturing regulations, and stated the company had not taken adequate steps to address and correct the violations.
Without the proper quality checks in place, the FDA warns that the GenStrip glucose readings could be inaccurate, and people could end up with dangerously high or low glucose levels or conditions such as acute hyperglycemia.
What Should GenStrip Users Do?
Shasta Technologies has so far refused to voluntarily issue a product recall for its GenStrip blood glucose test strips. Therefore, the product remains on sale throughout the United States. The FDA recommends that all consumers immediately discontinue using GenStrips and switch to an alternative brand of test strips intended to be used with LifeScan OneTouch meters. The FDA is also communicating with retailers and distributors involved in the sale of GenStrips in order to stop any further distribution or sale of this potentially harmful product.
Potential for GenStrips Lawsuits
So far, no injuries have been reported due to the potentially unsafe GenStrips. However, many people may not be aware of the FDA warning or potential risks and may continue using GenStrips. If you or anyone else suffers a serious medical injury or other harm due to inaccurate glucose readings caused by GenStrips, you may be entitled to substantial compensation from Shasta Technologies.
The products liability lawyers at Lopez McHugh, LLP are dedicated to helping consumers recover for injuries and losses caused by defective products such as GenStrips. If you have suffered an injury or medical condition due to GenStrips, call our office today (877) 737-8525 to schedule a free consultation and discuss a possible case.