APTIMA CV/TV ASSAY

Additional Manufacturer Narrative

HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. TS INFORMED THE CUSTOMER THAT RESULTS FROM DIFFERENT SAMPLES CANNOT BE COMPARED AS THEY ARE SEPARATE COLLECTIONS. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED A DISCREPANT RESULT USING APTIMA CV/TV ASSAY MASTER LOT 913344 WHEN TESTING SAMPLES ON PANTHER FUSION PLUS INSTRUMENTS. ON (B)(6) 2025, TWO SAMPLES FROM THE SAME PATIENT WERE TESTED ON CV/TV WL-003679-20250711-09 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV POSITIVE WHILE SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV NEGATIVE. CUSTOMER REPORTED BOTH RESULTS TO THE PHYSICIAN/PATIENT. ON (B)(6) 2025, BOTH SAMPLES WERE RETESTED ON CV/TV WL-004306-20250716-08 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6). SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TC POSITIVE AGAIN BUT SAMPLE SID (B)(6) RESULTED CV NEGATIVE / TV POSITIVE. ON THE SAME DAY THE CUSTOMER RETESTED SID (B)(6) ONE MORE TIME ON CV/TV WL-004304-20250716-03 ON PANTHER FUSION PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RESULTED CV NEGATIVE / TV POSITIVE AGAIN. CUSTOMER NOTED THEY WOULD AMEND THE SID (B)(6) RESULT TO CV NEGATIVE / TV POSITIVE. CUSTOMER DID NOT HAVE ANY INFORMATION RELATED TO PATIENT TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.