inforMED
MalfunctionSCA

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

Received Mar 31, 2026 · Event occurred Mar 17, 2026

Report 2531491-2026-00086 · MDR key 24749869

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). THESE COMBO TESTS DON'T WORK WELL, ACCORDING TO STUDIES THEY MISS A HUGE PORTION OF POSITIVES. I WAS MISLED BY THE INFLUENSTER REVIEWS WHO GOT IT FOR FREE. I WAS ON A ROAD TRIP WITH SOMEONE WHO TESTED POSITIVE FOR INFLUENZA B AND TWO DAYS LATER I HAVE ALL OF THE SAME SYMPTOMS (FEVER, DRY COUGH, BODY ACHES). YET THIS TEST SHOWED NEGATIVE FOR ALL. SAVE YOUR MONEY AND GET A DEDICATED TEST OR LAB TEST.

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.