APTIMA COMBO 2 ASSAY
Received Jul 21, 2026 · Event occurred Jun 24, 2026
Report 2024800-2026-00046 · MDR key 25895851
Device
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, A CUSTOMER IN UNITED KINGDOM REPORTED TO HOLOGIC THAT A DISCREPANT RESULT WAS GENERATED WHILST USING THE AC2 ASSAY (MASTER LOT: 930679) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER CPT-02110133. ON (B)(6) 2026, SAMPLE ID (B)(6) WAS TESTED IN PANTHER WORKLIST ID (B)(6) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE / NEISSERIA GONORRHEA (GC) NEGATIVE RESULT. THE SAME SAMPLE (ID (B)(6) WAS RETESTED ON ANOTHER PANTHER INSTRUMENT AND GENERATED A NEISSERIA GONORRHOEAE (GC) POSITIVE RESULT. LATER, THE SAMPLE WAS RETESTED AGAIN ON THE PANTHER INSTRUMENT AND GENERATED A NEISSERIA GONORRHEA (GC) NEGATIVE RESULT. NO INFORMATION REGARDING PATIENT TREATMENT IS AVAILABLE AT THIS TIME. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOME RELATED TO THIS EVENT.
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE PANTHER SYSTEM LOG FILES PROVIDED BY THE CUSTOMER. THE PRELIMINARY ANALYSIS INDICATES THAT THE DISCREPANT RESULT MAY BE DUE TO EXTERNAL INTRODUCTION OF MATERIAL AFTER THE SAMPLE WAS TESTED ON THE PANTHER SYSTEM, OR POTENTIAL CROSS-CONTAMINATION DURING SAMPLE HANDLING AND PROCESSING. REVIEW OF THE LOGS DID NOT REVEAL ANY HARDWARE OR INSTRUMENT ISSUES THAT CONTRIBUTED TO THE DISCREPANT RESULT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.