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). (CUSTOMER LEFT THE SAME EXACT REVIEW ON THE SAME DAY FOR BOTH CVS & WALGREENS) DO NOT RECOMMENDED. WAS EASY TO USE BUT DID NOT GIVE ME POSITIVE RESULTS. I TESTED ON A THURSDAY AM FOR FEELING AWFUL AND IT CAME BACK NEGATIVE. WENT TO URGENT CARE NEXT AM AND WAS POSITIVE FOR FLU B.