APTIMA COMBO 2 ASSAY

Description of Event or Problem

ON (B)(6) 2025, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS WHILE RUNNING THE APTIMA COMBO 2 (AC2) ASSAY (ML 922619) ON THEIR PANTHER FUSION PLUS INSTRUMENT (SN (B)(6). ON (B)(6) 2025, CUSTOMER INITIALLY TESTED SAMPLE ID (SID) (B)(6) ON AC2 WORKLIST (WL) (B)(4) AND RECEIVED AN INVALID RESULT DUE TO CI FLAG ON THE NEISSERIA GONORRHOEAE (GC) POSITIVE CONTROL. CUSTOMER THEN RERAN THE SAME SAMPLE TUBE ON THE SAME DAY ON AC2 WL (B)(4) AND RECEIVED A VALID CHLAMYDIA TRACHOMATIS (CT) EQUIVOCAL, GC NEGATIVE RESULT. CUSTOMER REPORTED OUT THE GC NEGATIVE RESULT BUT RETESTED THE CT EQUIVOCAL RESULT PER PACKAGE INSERT. ON (B)(6) 2025, CUSTOMER RETESTED THE SAME SAMPLE TUBE ON AC2 WL (B)(4) AND RECEIVED A CT POSITIVE, GC POSITIVE RESULT. CUSTOMER REPORTED OUT THE CT POSITIVE RESULT. CUSTOMER LATER PERFORMED AN ADDITIONAL RETEST OF THE SAMPLE ON (B)(6) 2025, ON AC2 WL (B)(4) AND RECEIVED A CT POSITIVE, GC POSITIVE RESULT. CUSTOMER DETERMINED TO AMEND THE RESULT AND REPORT THE GC POSITIVE RESULT. CUSTOMER NOTED THAT THE PATIENT WAS TREATED FOR CT DUE TO KNOWN EXPOSURE BUT DID NOT PROVIDE FURTHER PATIENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

Additional Manufacturer Narrative

HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. WHILE THE CAUSE OF THE OBSERVED DISCREPANT RESULT IS UNKNOWN, POSSIBLE CAUSES INCLUDE LOW LEVEL TARGET CONCENTRATION IN THE SAMPLE OR SAMPLE HANDLING. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.