DIMENSION VISTA®

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT DIMENSION VISTA® MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL) LOT 7BDA81 MAY HAVE AN INCOMPLETE SLIT ON THE SEPTUM IN THE CAP OF THE VIAL. A DILUENT CAP WITH A DEFECTIVE SEPTUM HAS THE POTENTIAL TO CAUSE ERRONEOUSLY ELEVATED RESULTS IF A SAMPLE IS AUTODILUTED ONBOARD THE DIMENSION VISTA SYSTEM, DUE TO A REDUCED VOLUME OF DILUENT BEING PIPETTED FROM THE VIAL. MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL) IS USED FOR DILUTIONS OF SAMPLES EXCEEDING THE ANALYTICAL MEASUREMENT RANGE WITH THE DIMENSION VISTA® ESTRADIOL (E2) FLEX REAGENT CARTRIDGE. URGENT MEDICAL DEVICE RECALL, VC-18-04.A.US DATED MARCH 21, 2018 AND URGENT FIELD SAFETY NOTICE VC-18-04.A.OUS DATED MARCH 2018 WERE ISSUED TO CUSTOMERS WHO HAD BEEN SHIPPED DIMENSION VISTA® MULTI 1 SAMPLE DILUENT (MULTI 1 SDIL) LOT 7BDA81 TO INFORM THEM OF THE ISSUE.

Description of Event or Problem

A FALSELY ELEVATED ESTRADIOL (E2) RESULT WAS OBTAINED ON A CAP SURVEY SAMPLE ON THE DIMENSION VISTA 500 INSTRUMENT. THE RESULT WAS SCORED AS UNACCEPTABLE BY THE CAP. THERE IS NO INDICATION THAT PATIENT SAMPLES HAVE BEEN AFFECTED.