FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST
Received Mar 10, 2026 · Event occurred Feb 26, 2026
Report 2531491-2026-00052 · MDR key 24559214
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
Description of Event or Problem
INVALID RESULT(S): MISALIGNED TEST STRIP (RSV). THE END USER REPORTED THAT THE CONTROL (CTL) LINE ON THE TEST STRIP FOR RSV (R) DEVELOPED BUT IT WAS IN BETWEEN THE CTL AND R MARKINGS. 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.
Description of Event or Problem
INVALID RESULT(S): MISALIGNED TEST STRIP (RSV). THE END USER REPORTED THAT THE CONTROL (CTL) LINE ON THE TEST STRIP FOR RSV (R) DEVELOPED BUT IT WAS IN BETWEEN THE CTL AND R MARKINGS. THE TEST STRIP FOR COV/FLU APPEARED NORMAL.
Additional Manufacturer Narrative
CASE OUTCOME: THE PROPOSED VARIANCE USING THE REDUNDANT QS0001 FORM B ALONG WITH THE QS0001 FORM A REMAINS COMPLIANT WITH APPLICABLE REGULATORY REQUIREMENTS (E.G., FDA 21 CFR 820.198 AND ISO 13485:2016 §8.2.2), PROVIDED THAT: ALL REQUIRED COMPLAINT DATA ELEMENTS ARE RETAINED INVESTIGATION RECORDS REMAIN COMPLETE, ACCURATE, AND TRACEABLE REVIEW AND APPROVAL BY DESIGNATED PERSONNEL (INCLUDING SMES) IS DOCUMENTED THERE IS NO DIRECT IMPACT TO PRODUCT QUALITY. 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.