APTIMA COMBO 2 ASSAY

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER REPORTED A DISCREPANT RESULT USING THE APTIMA COMBO 2 (AC2) ASSAY ON THEIR PANTHER INSTRUMENT. ON (B)(6) 2025, SAMPLE ID: (B)(6) RESULTED AS GC POSITIVE, CT NEGATIVE WITH MASTER LOT 922619 ON WORKLIST (B)(4). CUSTOMER REPORTED THEY HAVE MADE IT THEIR LAB POLICY TO RETEST ANY POSITIVE RESULT WITH AN RLU VALUE BELOW 1000. ON (B)(6) 2025, CUSTOMER RERAN THE SAMPLE USING THE SAME MASTER LOT ON WORKLIST (B)(4) WHERE IT RESULTED AS DOUBLE CT NEGATIVE / GC NEGATIVE. CUSTOMER RELAYED THE INITIAL POSITIVE RESULT WAS HELD BACK, BUT DUE TO HOW THEIR LIS WAS PROGRAMMED, THE NEGATIVE RESULT WAS TRANSMITTED TO THE CAREGIVER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

Additional Manufacturer Narrative

HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND WORKLISTS AND FOUND NO EVIDENCE OF RELEVANT HARDWARE ERRORS OR THAT THERE WERE REAGENT PREPARATION OR CONTAMINATION ISSUES. TS ADVISED CUSTOMER THAT PER THE AC2 PACKAGE INSERT, THE FIRST VALID RESULT SHOULD BE REPORTED. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.