inforMED
MalfunctionSCA

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

Received Apr 13, 2026 · Event occurred Apr 2, 2026

Report 2531491-2026-00098 · MDR key 24865062

Device

Generic name

Covid-19 Multi-analyte Antigen Device

Product problems

  • Unable to Obtain Readings

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

INVALID RESULT(S). INSTRUCTIONS ARE CLEAR BUT THE TEST WAS UNRESPONSIVE. IT DIDN'T GIVE ANY ANSWERS. EASY DISPOSAL. I'D RECOMMEND GETTING A SECOND OPINION IF YOU THINK YOU'RE POSITIVE.