APTIMA COMBO 2 ASSAY
Received Oct 30, 2025 · Event occurred Oct 17, 2025
Report 2024800-2025-00071 · MDR key 23426155
Device
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2025, CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT CHLAMYDIA TRACHOMATIS (CT) RESULTS ON A SAMPLE WHILE USING THE APTIMA COMBO 2 ASSAY (AC2, ML 915869) ON THEIR PANTHER INSTRUMENT (SN (B)(6). ON (B)(6) 2025, CUSTOMER TESTED SAMPLE ID (SID) (B)(6) ON PANTHER WORKLIST (WL) (B)(4) AND RECEIVED CT POSITIVE, GC EQUIVOCAL RESULTS. CUSTOMER DID NOT REPORT OUT INITIAL RESULTS. DUE TO THE GC EQUIVOCAL RESULT, CUSTOMER RETESTED THE SAMPLE FROM THE SAME TUBE ON (B)(6) 2025, ON PANTHER WORKLIST (WL) (B)(4) AND RECEIVED CT NEGATIVE, GC POSITIVE RESULTS. CUSTOMER DID NOT PROVIDE ADDITIONAL 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. HOLOGIC INFORMED CUSTOMER THAT PER THE AC2 ASSAY PACKAGE INSERT, THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED. CUSTOMER UNDERSTOOD AND DETERMINED TO REPORT OUT THE RESULT AS CT POSITIVE, GC POSITIVE. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.