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
Manufacturer
Acon Laboratories, Inc.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.