FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 10, 2026 · Event occurred Mar 2, 2026
Report 2531491-2026-00062 · MDR key 24559358
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). FALSE NEGATIVE FOR RSV. THE END USER REPORTED RECEIVING A PCR TEST AT THE ER ON (B)(6) 2026 AND THE RESULT WAS POSITIVE FOR RSV. THEN, THE END USER TESTED WITH A FLOWFLEX PLUS RSV TEST ON (B)(6) 2026 AND THE RESULT WAS NEGATIVE. THEY TESTED AGAIN WITH A FLOWFLEX PLUS RSV TEST ON (B)(6) 2026 AND THE RESULT WAS NEGATIVE. THEY CONFIRMED THAT THEY'D DISPOSED OF ALL THE TEST MATERIALS PRIOR TO CONTACTING ACON SO THEY WERE UNABLE TO PROVIDE ANY LOT INFORMATION.