DIASORIN LIAISON MDX

Description of Event or Problem

THE LIAISON MDX IS A DESKTOP REAL-TIME POLYMERASE CHAIN REACTION ANALYZER. THE INSTRUMENT USES THE 560 NANOMETERS (FLUORESCEIN AMIDITE) CHANNEL FOR LIQUID LEVEL SENSING. FOR SEVERAL YEARS, THIS CHANNEL HAS EXHIBITED ERRORS LEADING TO FREQUENT "ISV" (INSUFFICIENT VOLUME) ERROR CODES. THESE ERRORS PREVENT ANALYZERS FROM PASSING VERIFICATION TESTING AT CUSTOMER SITES, DELAYING PATIENT RESULTS. THIS REPORT IS SUBMITTED BY AN EMPLOYEE OF THE LEGAL MANUFACTURER'S SUBSIDIARY (DIASORIN MOLECULAR LLC AND LUMINEX), ACTING AS AN INTERNAL OBSERVER. BASED ON INTERNAL KNOWLEDGE, MORE THAN 50 ANALYZERS HAVE BEEN REPLACED DUE TO THIS FAILURE MODE SINCE 2023. EXAMPLE INCIDENTS INCLUDE: ¿ IN 2023-2025, MULTIPLE ANALYZERS DEPLOYED TO U.S. LABORATORIES FAILED INITIAL CUSTOMER VALIDATION DUE TO REPEATED ISV ERRORS ON THE FAM CHANNEL. A. (B)(6) - 4 ANALYZERS FAILING DUE TO ISV REPLACED - ALL FOUR THAT WERE SENT FAILED DUE TO ISV - ALL WERE AGAIN REPLACED. B. (B)(6) - MULTIPLE UNITS REPLACED - THEN REPLACED AGAIN. ¿ IN ONE CASE, A UNIT SHIPPED TO A CLINICAL SITE FAILED WITHIN 48 HOURS AND WAS REPLACED, BUT NO PERMANENT CORRECTIVE ACTION WAS IMPLEMENTED. TO DATE, DEVICES ARE BEING REPLACED ON A ROLLING BASIS WITHOUT A TECHNICAL FIX. THE ISSUE HAS NOT BEEN FORMALLY RESOLVED OR CORRECTED, DESPITE ITS IMPACT ON TIMELY PATIENT RESULTS.