FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received May 11, 2026 · Event occurred May 5, 2026
Report 2531491-2026-00126 · MDR key 25144504
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Product problems
- Imprecise or Erratic Results
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
INACCURATE RESULT(S). WE GOT AN EMAIL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH A FLOWFLEX PLUS COVID 19 AND FLU A/B ANTIGEN TEST KIT. THE CUSTOMER JUST PURCHASED THE TEST KIT, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY AND THE RESULT WAS POSITIVE FOR FLU A, NEGATIVE FOR FLU B, NEGATIVE FOR COVID. THE CUSTOMER TESTED THE NEXT DAY WITH FLOWFLEX PLUS 4N1, AND THE RESULT WAS POSITIVE FOR FLU B, NEGATIVE FOR FLU A. THE CUSTOMER HAS THROWN AWAY THE TEST CASSETTES AND THE BOXES, SO WE COULD NOT COLLECT THE LOT NUMBER AND EXPIRATION DATE. I ADVISED THE CUSTOMER THAT I WOULD FORWARD THE INFORMATION TO THE COMPLAINT TEAM FOR REVIEW. THE CUSTOMER WILL AWAIT AN EMAIL BACK FROM ACON LABS.