SEKISUI DIAGNOSTICS SILARIS FLU PCR
Received May 10, 2019 · Event occurred Jan 1, 2019
Report MW5086579 · MDR key 8604941
Device
Generic name
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Manufacturer
Mesabiotech, Inc.Model number
SILARISCatalog number
1027
Lot number
18052201
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
SEKISUI PRODUCT: SILARIS, REF # 1027 BY MESABIOTECH, INFLUENZA A AND B PCR. THIS PRODUCT PRODUCES ERRONEOUS AND OR NO RESULTS 40% OF THE RUNS, WHEN DIRECTIONS WERE FOLLOWED IN PACKAGE INSERT AND INSTRUCTION MANUAL BY SEKISUI. THIS HAS BEEN REPORTED TO SEKISUI DIAGNOSTICS AND THEY HAVE REPORTED IT TO MESABIOTECH. ALL SEKISUI TEST KITS AND DOCK STATIONS TO RUN THE INFLUENZA A AND B TESTS HAVE BEEN RETURNED TO SEKISUI DIAGNOSTICS. SEKISUI IS AWARE OF THE RESULTING ISSUES WITH THIS MACHINE AND DEVICE AND THEY HAVE BEEN SENT EXAMPLES OF CASSETTES THAT DO NOT RESULT OR WHEN THE MACHINE SAYS "INVALID TEST" OR SAYS "TEST DEVICE NOT INSERTED" EVEN WHEN IT IS INSERTED PROPERLY. PHOTOS OF RUN CASSETTES WITH NO RESULTS AND NO QC CONTROL LINE.