APTIMA COMBO 2 ASSAY; APTIMA CONTROLS KIT

Additional Manufacturer Narrative

ON (B)(6) 2025, CUSTOMER QUESTIONED THEIR RESULTS WITH HOLOGIC¿S APTIMA COMBO 2 READY-MADE-REAGENTS ASSAY (MASTER LOT 909330) AS THEY HAD LOWER THAN EXPECTED RLUS FOR THEIR CHLAMYDIA (CT) POSITIVE CONTROLS ACROSS AT LEAST SIX PANTHER INSTRUMENTS (SERIAL NUMBERS: (B)(6) WITH THE LAST NOT REPORTED) FOR RESULTS OBTAINED (B)(6) 2025, WHERE THEY SUSPECTED A CONTAMINATION ISSUE. CUSTOMER PERFORMED CLEANING OF TOUCHPOINT AREAS WITH 50% BLEACH SOLUTION (WHICH IS OFF-LABEL AS THE HOLOGIC PACKAGE INSERT DETAILS A CONCENTRATION OF 2.5-3.5%) AND REPORTED THAT THE ISSUE PERSISTED. CUSTOMER REPORTED OUT THE RESULTS, WITH CUSTOMER LAST REPORTING THEY HAVE NOT AMENDED ANY RESULTS. CUSTOMER HAS NOT REPORTED THAT THEY PLAN TO AMEND RESULTS, AND NO RETESTING OF SAMPLES IS KNOWN. CUSTOMER DID NOT UPLOAD COMPREHENSIVE LOG FILES. THE FOLLOWING WORKLIST INFORMATION IS KNOWN: (B)(6) ¿ 6 CT POSITIVE SAMPLES (B)(6) ¿ 8 CT POSITIVE SAMPLES (B)(6) ¿ 13 CT POSITIVE SAMPLES (B)(6) ¿ 2 CT POSITIVE SAMPLES OF THE CT POSITIVE SAMPLES OR CONTROLS, NONE HAD RLUS ABOVE 1000 FOR ALL REPORTED WORKLISTS. TECHNICAL SUPPORT (TS) REVIEWED PROVIDED INFORMATION AND FOUND THERE WAS POSSIBLE INHIBITION, INDICATING THE POTENTIAL FOR FALSE NEGATIVE RESULTS, AND ADVISED CUSTOMER TO DISCARD OPEN ITEMS (CONTROLS, CONSUMABLES, ETC.), TO CLEAN ALL SAMPLE AND REAGENT PREPARATION AREAS AND TOUCHPOINTS, AND TO PREPARE NEW KITS AND TO RUN 5 CT CONTROLS AS SAMPLES TO ASSESS PERFORMANCE. CUSTOMER SUBSEQUENTLY CONFIRMED THEY HAD RUNS THAT IMPROVED IN PERFORMANCE. CUSTOMER THEN REPORTED THAT THEY SWITCHED TO A NEW MASTER LOT (911701) AND HAVE NOT SEEN ANY ISSUES, WITH CT CONTROL RLUS EXCEEDING 1000. TS RELAYED THAT FOR THE RUNS OF CONCERN, THEY SAW NO OBVIOUS HARDWARE ISSUES AND THAT SOME INSTRUMENTS HAD RUNS/KITS IN BETWEEN THAT HAD CONTROL LOTS EXCEEDING 1000 WITH MASTER LOT 909330. NEW LOGS FROM THESE RUNS HAVE NOT BEEN CURRENTLY PROVIDED FOR REVIEW.

Description of Event or Problem

CUSTOMER QUESTIONED THEIR RESULTS WITH HOLOGIC¿S APTIMA COMBO 2 READY-MADE-REAGENTS ASSAY (MASTER LOT 909330) AS THEY HAD LOWER THAN EXPECTED RLUS FOR THEIR CHLAMYDIA (CT) POSITIVE CONTROLS ACROSS AT LEAST SIX PANTHER INSTRUMENTS (SERIAL NUMBERS: (B)(6), WITH THE LAST NOT REPORTED) WHERE THEY SUSPECTED A CONTAMINATION ISSUE. CUSTOMER PERFORMED CLEANING OF TOUCHPOINT AREAS WITH 50% BLEACH SOLUTION (WHICH IS OFF-LABEL AS THE HOLOGIC PACKAGE INSERT DETAILS A CONCENTRATION OF 2.5-3.5%) AND REPORTED THAT THE ISSUE PERSISTED. CUSTOMER REPORTED OUT THE RESULTS, WITH CUSTOMER LAST REPORTING THEY HAVE NOT AMENDED ANY RESULTS. CUSTOMER HAS NOT REPORTED THAT THEY PLAN TO AMEND RESULTS, AND NO RETESTING OF SAMPLES IS KNOWN. CUSTOMER DID NOT UPLOAD COMPREHENSIVE LOG FILES. THE FOLLOWING WORKLIST INFORMATION IS KNOWN: (B)(6) ¿ 6 CT POSITIVE SAMPLES (B)(6) ¿ 8 CT POSITIVE SAMPLES (B)(6) ¿ 13 CT POSITIVE SAMPLES (B)(6) ¿ 2 CT POSITIVE SAMPLES OF THE POSITIVES, NONE HAD RLUS ABOVE 1000. TECHNICAL SUPPORT REVIEWED UPLOADED INFORMATION AND FOUND THERE WAS POSSIBLE INHIBITION, INDICATING THE POTENTIAL FOR FALSE NEGATIVE RESULTS, AND ADVISED CUSTOMER TO DISCARD OPEN ITEMS, TO CLEAN ALL SAMPLE AND REAGENT PREPARATION AREAS AND TOUCHPOINTS, AND TO PREPARE NEW KITS AND TO RUN CONTROLS AS SAMPLES TO ASSESS PERFORMANCE. CUSTOMER SUBSEQUENTLY REPORTED THAT THEY SWITCHED TO A NEW MASTER LOT (911701) AND HAVE NOT SEEN ANY ISSUES. NEW LOGS FROM THESE RUNS HAVE NOT BEEN CURRENTLY PROVIDED FOR REVIEW.