FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Jan 23, 2026 · Event occurred Jan 7, 2026
Report 2531491-2025-00298 · MDR key 24172478
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). INVALID RESULT. THE USER REPORTED THAT THEIR CASSETTE DID NOT PRODUCE A CONTROL (CTL) LINE ON THE RSV TEST STRIP. PURCHASED FROM CVS.
Additional Manufacturer Narrative
CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR (B)(6) WERE REVIEWED AND IT WAS DETERMINED THAT THE ISSUE IS NOT PRESENT ON ANY OTHER PRODUCT AND THE PRODUCT WAS CONSIDERED ACCEPTABLE. ACCORDING TO THE RECORDS REVIEWED, THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. NO ISSUES HAVE BEEN DETECTED IN THE MANUFACTURING PROCESS AND QUALITY CONTROL INSPECTION, AND THE MANUFACTURING PROCESS COMPLIES WITH THE SOP. 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 RESULT. THE USER REPORTED THAT THEIR CASSETTE DID NOT PRODUCE A CONTROL (CTL) LINE ON THE RSV TEST STRIP. PURCHASED FROM CVS.