FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST

Description of Event or Problem

FALSE NEGATIVE RESULT(S). THE DIRECTIONS WERE VERY CLEAR WHICH I APPRECIATED. I HAD TO READ THEM OVER AND OVER TO MAKE SURE I WOULDN'T MISS ANY STEPS AS IT WAS VERY TECHNICAL. HOWEVER, WHEN WE WERE SICK MY TEST CAME UP NEGATIVE. BUT THE SAME DAY I TOOK MY SON TO HIS DOCTOR AND WHEN THEY TESTED HIM, HE WAS POSITIVE FOR FLU A. SO I'M NOT SURE HOW ACCURATE THIS IS.

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.