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
Manufacturer
Acon Laboratories, Inc.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.