FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 10, 2026 · Event occurred Mar 3, 2026
Report 2531491-2026-00065 · MDR key 24559362
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Lot number
RFC5118004
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): WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY, THE CONTROL LINE ON THE RIGHT-HAND SIDE WAS MISSING. THE CUSTOMER WAS ABLE TO SEND A PICTURE OF THE TEST CASSETTE. THE CUSTOMER COULD NOT OPEN THE TEST CASSETTE TO TAKE A PICTURE OF THE INSIDE COMPONENT LAYOUT.