FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 12, 2026 · Event occurred Mar 5, 2026
Report 2531491-2026-00079 · MDR key 24582011
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Product problems
- False Negative Result
Patient
NA · Unknown
- Insufficient Information
Narrative
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). FIRST OF ALL THE DIRECTIONS WERE VERY CONFUSING AND IT SAID NEGATIVE WHEN I THEN WENT TO THE DOCTOR TO FIND OUT THAT I DID IN FACT HAVE COVID, WHAT THE HECK! IT WAS VERY UNCOMFORTABLE USING THE TEST AND IT WAS NOT SENSITIVE AT ALL WHICH WAS VERY DISAPPOINTING. I AM BUMMED OUT BECAUSE THIS WAS A VERY POPULAR BRAND AND VALUE FRIENDLY SO I WAS HOPING IT WAS GOING TO WORK AND IT DID NOT AT ALL. IT WAS QUICK TO TEST WHICH IS THE ONLY POSITIVE FEEDBACK THAT I WILL SAY BUT OTHER THAN THAT I WILL NEVER USE THIS BRAND AGAIN SINCE IT GAVE ME AN INCORRECT RESULT.