WALGREENS URINARY TRACT INFECTION TEST STRIPS

Description of Event or Problem

SOURCE OF THE REPORT CAME FROM ECOMMERCE. PERFORMANCE RESULTS. CUSTOMER STATED "THE WALGREENS URINARY TRACT INFECTION TEST STRIPS ARE CONVENIENT AND EASY TO USE AT HOME. THE INSTRUCTIONS ARE CLEAR, AND THE RESULTS APPEAR QUICKLY. HOWEVER, THE ACCURACY CAN BE HIT OR MISS[?]I GOT DIFFERENT RESULTS FROM A LAB TEST, WHICH MADE ME QUESTION ITS RELIABILITY. IT'S A GOOD OPTION FOR A QUICK CHECK, BUT I WOULDN'T RELY ON IT ALONE FOR DIAGNOSING A UTI."

Additional Manufacturer Narrative

THE CURRENT COMPLAINT IS RELATED TO PERFORMANCE ISSUE OR DEVICE MALFUNCTION, BUT NO INFORMATION WAS PROVIDED FOR ACON TO CONDUCT AN INVESTIGATION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.