APTIMA COMBO 2 ASSAY

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING THE APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 913491 ON THE PANTHER PLUS INSTRUMENT (SERIAL NUMBER: (B)(6). ON (B)(6) 2025, SAMPLE ID (B)(6) WAS INITIALLY RUN ON WORKLIST (B)(4) AND RESULTED CT POSITIVE AND GC POSITIVE. THE SAME SAMPLE ID WAS RETESTED THE NEXT DAY UNDER WORKLIST (B)(4) AND RESULTED CT NEGATIVE AND GC NEGATIVE. CUSTOMER NOTED THEY WERE HOLDING RESULTS UNTIL A LOG REVIEW WAS PERFORMED. PER CUSTOMER LAB POLICY, THE SAMPLE IS RETESTED IF THERE IS A DUAL POSITIVE RESULT. CUSTOMER DID NOT CONFIRM IF THE DUAL POSITIVE OR THE NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

Additional Manufacturer Narrative

HOLOGIC REVIEWED ALL CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TO EXCLUDE CONTAMINATION, HOLOGIC ADVISED THE CUSTOMER TO PERFORM A GENERAL LAB CLEANING AND A RUN KNOWN CT POSITIVE AND BLANK PANELS BEFORE RUNNING THE INSTRUMENT AGAIN. HOLOGIC REVIEWED POST-CLEANING LOGS AND NOTED CONTROLS AND BLANKS RESULTED AS EXPECTED. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS DUE TO SAMPLE MISHANDLING. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.