FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Feb 23, 2026 · Event occurred Feb 12, 2026
Report 2531491-2026-00038 · MDR key 24416261
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): CUSTOMER PURCHASED A FLOWFLEX PLUS 4-IN-1 KIT WITH INVALID TEST RESULTS. THE RESULTS FOR RSV ARE INCONCLUSIVE. THE RED LINE FALLS BETWEEN THE CTL AND THE R. PICTURE PROVIDED.
Description of Event or Problem
INVALID RESULT(S): CUSTOMER PURCHASED A FLOWFLEX PLUS 4-IN-1 KIT WITH INVALID TEST RESULTS. THE RESULTS FOR RSV ARE INCONCLUSIVE. THE RED LINE FALLS BETWEEN THE CTL AND THE R. PICTURE PROVIDED.
Additional Manufacturer Narrative
CASE OUTCOME: REFER TO CPUS260137 FORM B INVESTIGATION REPORT (PREVIOUS INVESTIGATION FOR THE SAME ISSUE). RETENTION SAMPLES FROM LOT RFC5118004 WERE TESTED AND MET THE QC CRITERIA. THE ISSUE WAS NOT FOUND IN THE RETAINED CASSETTES. THE COMPLAINT IS NOT 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.