FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Jan 23, 2026 · Event occurred Jan 14, 2026
Report 2531491-2026-00004 · MDR key 24172511
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Product problems
- False Positive 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 POSITIVE RESULT(S). THE TEST SHOWED A CLEAR POSITIVE RED LINE ON "A", BUT AT THE DOCTOR'S OFFICE I TESTED NEGATIVE FOR FLU A AND B. "THAT'S A FALSE POSITIVE" ACCORDING TO THE DOCTOR AND A WASTE OF $24. FROM ME. DON'T WASTE YOUR MONEY. EST WAS INVALID. I FOLLOWED THE DIRECTIONS EXACTLY! WHAT A WASTE OF MONEY!