MalfunctionSCA
FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Apr 22, 2026 · Event occurred Apr 13, 2026
Report 2531491-2026-00106 · MDR key 24958777
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). FAILED TO CATCH MY FLU AFTER BEEN SICK MORE THAN 24 HOURS. I CHECK AGAIN WITH ANOTHER TEST I GOT FROM AMAZON AND CAME BACK POSITIVE. WENT TO URGENT CARE AND CONFIRMED THAT I HAD THE FLU. ANYWAY, THIS PRODUCT IS TRASH.