inforMED
MalfunctionSCA

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

Received Feb 3, 2026 · Event occurred Jan 28, 2026

Report 2531491-2026-00018 · MDR key 24250892

Device

Generic name

Covid-19 Multi-analyte Antigen Device

Product problems

  • False Negative Result

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

FALSE NEGATIVE RESULT(S). I BOUGHT THIS AT CVS AND A DIFFERENT TEST OFF AMAZON AND THIS GAVE A FALSE NEGATIVE FOR FLU A

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.