Description of Event or Problem · 0
THE ALETHIA CMV ASSAY TEST SYSTEM HAS BEEN IN USE IN OUR LABORATORY FOR THE CLINICAL TESTING OF CMV IN SALIVA SAMPLES FROM NEONATES YOUNGER THAN 21 DAYS SINCE (B)(6) 2022. THE TEST IS UTILIZED FOR DIAGNOSING CONGENITAL CMV. IN (B)(6) 2023, THE LABORATORY BEGAN EXPERIENCING REPEATED ENVIRONMENTAL CONTAMINATION EVENTS ASSOCIATED WITH THE USE OF THE ALETHIA TEST SYSTEM, WHICH WE WERE UNABLE TO RESOLVE. THE COMPANY MENTIONED THAT THE ASSAY IS PRONE TO CONTAMINATION AND PROVIDED A FEW STEPS THAT WE COULD TRY TO REDUCE THIS RISK. DESPITE REPLACING THE INSTRUMENT TWICE, CONTAMINATION REMAINED INEVITABLE. CONSEQUENTLY, WE BELIEVE THAT THIS ASSAY HAS A HIGH LIKELIHOOD OF PRODUCING FALSE-POSITIVE CLINICAL RESULTS AND SHOULD NOT BE USED FOR CLINICAL TESTING UNTIL THE COMPANY CONCLUSIVELY RESOLVES THE TECHNICAL ISSUES THAT INCREASE THE LIKELIHOOD OF CONTAMINATION. ON (B)(6) 2023, LEADERSHIP FROM THE (B)(6) HOSPITAL MET WITH MERIDIAN SENIOR LEADERSHIP TO GIVE AN OVERVIEW OF CONCERNS AND THE ISSUES ENCOUNTERED IN THE MONTHS PRECEDING THE MEETING. MERIDIAN'S VP OF REGULATORY AFFAIRS AND QUALITY ASSURANCE ACKNOWLEDGED THAT THE FDA HAD MERIDIAN ADD ADDITIONAL INFORMATION TO THEIR PACKAGE INSERT DUE TO THESE CONCERNS. THEY NOTED OTHER USERS HAD SUBMITTED FORMAL COMPLAINTS TO THE FDA AND RECOMMENDED WE SUBMIT A FORMAL COMPLAINT TO THE FDA IF WE FELT IT WAS APPROPRIATE. REFERENCE REPORT #MW5148322, #MW5148323.