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

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.

Description of Event or Problem

FALSE NEGATIVE RESULT(S). MY WHOLE FAMILY TOOK THESE TESTS AND ALL RESULTS WERE NEGATIVE. AFTER NOT TRUSTING THESE TESTS DUE TO HOW SICK WE FELT, WE ALL GOT TESTED AT THE DOCTOR OR TOOK OTHER AT HOME TESTS AND WERE VERY POSITIVE FOR RSV.