FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 10, 2026 · Event occurred Feb 26, 2026
Report 2531491-2026-00053 · MDR key 24559223
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
Description of Event or Problem
INVALID RESULT(S): INVALID TEST RESULT. THE END USER REPORTED THAT THE CONTROL (CTL) LINE ON THE TEST STRIP FOR RSV (R) DID NOT DEVELOP. THE TEST STRIP FOR COV/FLU APPEARED NORMAL.
Additional Manufacturer Narrative
CASE OUTCOME: REFER TO CPUS0137 FORM B INVESTIGATION REPORT (PREVIOUS INVESTIGATION FOR THE SAME ISSUE). ALL SAMPLES MEET QC SPECIFICATIONS, AND NO DEFECTS WERE OBSERVED. ALL SAMPLES SHOWED CORRECT RESULTS. BASED ON THE RETENTION SAMPLE TEST RESULTS, THE CUSTOMER'S COMPLAINT CAN'T BE CONFIRMED. THE FOLLOWING FIELDS ARE UPDATED: B4, "DATE OF THIS REPORT" - DATE OF THIS FOLLOW-UP REPORT. G6, "TYPE OF REPORT" - FOLLOW-UP #1 H2, "IF FOLLOW-UP, WHAT TYPE?" - ADDED "DEVICE EVALUATION" AND "ADDITIONAL INFORMATION" H3: RETENTION LOT WAS EVALUATED. H6 "ADVERSE EVENT PROBLEM" - EVENT PROBLEM AND EVALUATION CODES ARE UPDATED. H11 "ADDITIONAL NARRATIVE/DATA" - UPDATED MANUFACTURER'S NARRATIVE.
Description of Event or Problem
INVALID RESULT(S): INVALID TEST RESULT. THE END USER REPORTED THAT THE CONTROL (CTL) LINE ON THE TEST STRIP FOR RSV (R) DID NOT DEVELOP. THE TEST STRIP FOR COV/FLU APPEARED NORMAL.
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.