APTIMA CV/TV ASSAY

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 RESULTS IS UNKNOWN, IT IS POSSIBLE THE DISCREPANT RESULTS WERE DUE TO SAMPLE MISHANDLING OR LOW AMOUNT OF TARGET IN THE SAMPLE. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

Description of Event or Problem

ON FEBRUARY 10, 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON TWO SAMPLES WHILE USING THE APTIMA CV/TV ASSAY (ML 910984) ON THEIR PANTHER INSTRUMENT WITH SERIAL NUMBER (SN) (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED THE TWO SAMPLES ON CV/TV WORKLIST (WL) 002503-20260204-95 AND RECEIVED A TRICHOMONAS VAGINALIS (TRICH) NEGATIVE RESULT ON SAMPLE ID (SID) (B)(6) AND A CANDIDA (C) GLABRATA NEGATIVE RESULT ON SID (B)(6). ON (B)(6) 2026, CUSTOMER PERFORMED REPEAT TESTS FOR THESE SAMPLES ON CVTV WL 002503-20260209-19 AND RECEIVED A TRICH POSITIVE RESULT ON SID (B)(6) AND A C. GLABRATA POSITIVE RESULT ON SID (B)(6). CUSTOMER THEN REPEATED ALL NEGATIVE SAMPLES FROM WL 002503-20260204-95 AND RECEIVED TWO MORE SAMPLES WITH DISCREPANT RESULTS. SIDS (B)(6) BOTH INITIALLY RESULTED TRICH NEGATIVE. ON (B)(6) 2026, CUSTOMER PERFORMED A REPEAT TEST AND RECEIVED A TRICH POSITIVE RESULT FOR SID (B)(6) ON CV/TV WL 002503-20260210-14 AND A TRICH POSITIVE RESULT FOR SID (B)(6) ON CV/TV WL 002503-20260210-17. CUSTOMER DECIDED THAT ALL SAMPLES FROM THE INITIAL CV/TV WL 002503-20260204-95 WILL BE RESULTED AS INDETERMINATE. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.