There have been no recalls or quality failures logged for this product by the FDA or any other regulating authority since the inception of the product some 15 years ago. We are not responsible for procedure errors or failure to follow instructions etc. The instructions are very clear but a new consumer may fail to follow instructions exactly, be unfamiliar with routine testing procedures or be unfamiliar with reading test results. If an error is made in doing a test like pre-triggering an automatic lancet rendering it unusable, adding too much water to the reagents etc by not following instructions, we are not responsible.