FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 10, 2026 · Event occurred Feb 26, 2026
Report 2531491-2026-00068 · MDR key 24559434
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). FALSE NEGATIVE RESULT FOR COVID. THE END USER REPORTED THAT THEY TESTED WITH FLOWFLEX 4-IN-1 ON (B)(6)25 AND RECEIVED A NEGATIVE RESULT. THEN, THEY TESTED WITH A BINAX COVID TEST AND AN IHEALTH COVID TEST AND BOTH WERE POSITIVE FOR COVID. THEY CONFIRMED THAT THEY DISPOSED OF ALL TEST CONTENTS PRIOR TO CONTACTING ACON LABS SO THEY WERE UNABLE TO PROVIDE ANY LOT NUMBERS OR EXPIRATION DATES OR PROVIDE PICTURES OF THE TEST RESULTS.
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.