FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Jan 23, 2026 · Event occurred Jan 20, 2026
Report 2531491-2026-00007 · MDR key 24172528
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). THE RESULTS FOR THE RSV, FLU A AND B, AND COVID SHOWED NEGATIVE. WE WENT TO CENTRA CARE 2 DAYS AFTER AND THE RESULT WAS POSITIVE FOR FLU A. THIS UNRELIABLE AND INACCURATE TEST RESULT CAN POTENTIALLY PLACE THE HEALTH OF OTHERS AT RISK WHO CAME IN CONTACT WITH MY HUSBAND THINKING THE RESULTS WERE NEGATIVE.