Description of Event or Problem · 0
WE FIRST ENCOUNTERED INCREASED RATES OF "REACTIVE" TEST RESULTS (FROM BASELINE RATE OF (B)(4)) WITH 2 LOTS OF THE ELECSYS ANTI-HBC IGM ASSAY KITS (PRODUCT NO. 07026811160; ROCHE DIAGNOSTICS, INC., INDIANAPOLIS, IN) USED ON THE COBAS E 801 IMMUNOCHEMISTRY ANALYZERS (ROCHE DIAGNOSTICS) AT 3 OF OUR CLINICAL LABORATORIES DURING THE MONTH OF SEPTEMBER 2024. THE 2 AFFECTED KITS LOTS AND EXPIRATION DATES ARE DETAILED IN THE ADDITIONAL COMMENT SECTION OF THE RELEVANT TESTS/LABORATORY DATA BELOW. OF THE 19 RESIDUAL CLINICAL SERUM SPECIMENS WITH SUCH RESULTS AT ONE OF THE LABORATORY SITES, 7 WERE NON-REACTIVE BY THE ELECSYS ANT-HBC II (TOTAL ANTIBODY) ASSAY (PRODUCT NO. 0702679016; ROCHE DIAGNOSTICS), CONTRADICTING THE REACTIVE ELECSYS ANTI-HBC IGM RESULTS IN THESE SAME SPECIMENS. THESE SAME SPECIMENS WERE SENT TO ANOTHER CLINICAL LABORATORY FOR TESTING WITH THE ADVIA CENTAUR HBC IGM ASSAY (SIEMENS HEALTHCARE DIAGNOSTICS, INC.) THAT YIELDED NONREACTIVE RESULTS. WE HAVE NOTIFIED TECHNICAL SUPPORT DIVISION OF ROCHE DIAGNOSTICS IN EARLY OCTOBER 2024, AND WE ARE INFORMED THAT THERE IS NO OTHER LOT AVAILABLE FOR THE ELECSYS ANTI-HBC IGM ASSAY UNTIL DECEMBER 2024. FALSE-REACTIVE ANTI-HBC IGM TEST RESULTS CAN LEAD TO INCORRECT DIAGNOSIS OF ACUTE OR RECENT HEPATITIS B AND MAY DELAY DIAGNOSIS OF THE CORRECT UNDERLYING ILLNESSES IN THE AFFECTED INDIVIDUALS. MULTIPLE DATES OF TESTING USING THE 2 SPECIFIC LOTS OF ELECSYS ANTI-HBC IGM ASSAY (PRODUCT NO. 07026811160; ROCHE DIAGNOSTICS, INC., INDIANAPOLIS, IN) YIELDED FALSE REACTIVE RESULTS: 7780501 (EXPIRING 1-31-2025) AND 819879 (EXPIRING 5-31- 2025). REF REPORT: MW5163191.