inforMED
MalfunctionSCA

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

Received Apr 30, 2026 · Event occurred Apr 16, 2026

Report 2531491-2026-00111 · MDR key 25049033

Device

Generic name

Covid-19 Multi-analyte Antigen Device

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). TEST SAID I WAS NEGATIVE WENT TO DOCTORS AND WAS POSITIVE. I WON'T BUY AGAIN. - FALSE NEGATIVE RESULTS.