FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Feb 5, 2026 · Event occurred Jan 30, 2026
Report 2531491-2026-00023 · MDR key 24270793
Device
Generic name
Covid-19 Multi-analyte Antigen Device
Manufacturer
Acon Laboratories, Inc.Lot number
RFC5118003
Product problems
- Unable to Obtain Readings
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
CASE OUTCOME: BATCH RECORDS FOR FINAL PRODUCT MANUFACTURE AND QC RECORD FOR RFC5118003 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 COULD NOT BE CONFIRMED.
Description of Event or Problem
INVALID RESULT(S). CUSTOMER PERFORMED THE FLOWFLEX PLUS 4-IN-1 TEST AND RECEIVED INVALID RESULTS. NO CTL LINE APPEARED IN THE COVID/FLU SECTION. SHE PERFORMED THE TEST CORRECTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. THE KIT WAS PURCHASED AT OSCO. PICTURE PROVIDED.
Description of Event or Problem
INVALID RESULT(S): CUSTOMER PERFORMED THE FLOWFLEX PLUS 4-IN-1 TEST AND RECEIVED INVALID RESULTS. NO CTL LINE APPEARED IN THE COVID/FLU SECTION. SHE PERFORMED THE TEST CORRECTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. THE KIT WAS PURCHASED AT OSCO. PICTURE PROVIDED.
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.