FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Apr 13, 2026 · Event occurred Apr 6, 2026
Report 2531491-2026-00101 · MDR key 24865177
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Lot number
RFC5018004
Product problems
- Unable to Obtain Readings
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM ACON'S CONTRACT MANUFACTURER. ACON WILL SUBMIT A FOLLOW-UP MDR UPON INVESTIGATION COMPLETION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE INCLUDED WITH A FOLLOW-UP MDR.
Description of Event or Problem
INVALID RESULT(S). CUSTOMER PURCHASED A FLOWFLEX PLUS 4-IN-1 KIT THAT PROVIDED INVALID RESULTS. ONLY THE CTL APPEARED ON THE COVID/FLUA&B SIDE. NO CTL LINE APPEARED ON THE RSV SIDE. HE FOLLOWED THE DIRECTIONS EXACTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. CUSTOMER DECLINED A REPLACEMENT AND IS NOT WILLING TO SEND A PICTURE OF THE TEST CASSETTE SHOWING THE INVALID RESULTS.