FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Apr 13, 2026 · Event occurred Apr 2, 2026
Report 2531491-2026-00100 · MDR key 24865162
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). THE USER REPORTED THAT THEIR TEST DID NOT PRODUCE A CONTROL LINE FOR RSV BUT DID PRODUCE A FAINT TEST LINE. THEY CONFIRMED THAT THEY HAD A CONTROL LINE FOR COVID AND FLU. PURCHASED FROM ALBERTSONS.
Additional Manufacturer Narrative
CASE OUTCOME: REFER TO CPUS260137 FORM B INVESTIGATION REPORT (PREVIOUS INVESTIGATION FOR THE SAME ISSUE). THE TEST RESULTS OF RETENTION SAMPLES FROM RFC5118004 MET THE QC CRITERIA. THE COMPLAINT ISSUE WAS NOT FOUND FROM THE RETAINED CASSETTES. THE COMPLAINT IS NOT VERIFIED. 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.
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). THE USER REPORTED THAT THEIR TEST DID NOT PRODUCE A CONTROL LINE FOR RSV BUT DID PRODUCE A FAINT TEST LINE. THEY CONFIRMED THAT THEY HAD A CONTROL LINE FOR COVID AND FLU. PURCHASED FROM ALBERTSONS.