APTIMA COMBO 2 ASSAY

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULT USING THE APTIMA COMBO 2 ASSAY (AC2) FROM MASTER LOT 919672 ON THE PANTHER PLUS INSTRUMENT (SN: (B)(6). THE CUSTOMER INITIALLY TESTED THE SAMPLE ON (B)(6) 2025 UNDER WORKLIST (B)(4) AND RECEIVED A DUAL POSITIVE RESULT (CT POSITIVE/GC POSITIVE). THE SAME SAMPLE WAS RETESTED ON (B)(6) 2025 UNDER WORKLIST (B)(4) AND RESULTED DUAL NEGATIVE (CT NEGATIVE/GC NEGATIVE). THE CUSTOMER REPORTED OUT THE DUAL NEGATIVE RESULT (CT NEGATIVE/GC NEGATIVE). 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 THAT WOULD IMPACT THE RESULTS. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS DUE TO SAMPLE MISHANDLING OR A LOW TARGET SAMPLE. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.