APTIMA COMBO 2 ASSAY
Received Jul 17, 2026 · Event occurred Jun 12, 2026
Report 2024800-2026-00043 · MDR key 25864174
Device
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HOLOGIC SME REVIEWED THE PANTHER LOG FILES AND THE AC2 WORKLIST ID 1010910581-20260614-13 WAS VALID, WITH CONTROL RLUS WITHIN RANGE AND NO HARDWARE ERRORS THAT COULD HAVE INTERFERED WITH THE RESULTS. IN THAT RUN, THE SAMPLE WAS GC POSITIVE WITH AN RLU OF 228. THIS LOW RLU SUGGESTS A TARGET CONCENTRATION NEAR THE LIMIT OF DETECTION, AND IT IS NOT POSSIBLE TO DISTINGUISH WHETHER THE DETECTED TARGET ORIGINATED FROM THE SAMPLE OR FROM POSSIBLE TUBE OR CAP CROSS CONTAMINATION. NO INFORMATION REGARDING PATIENT TREATMENT IS AVAILABLE AT THIS TIME. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOME RELATED TO THIS EVENT.
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 APTIMA COMBO 2 (AC2) ASSAY (MASTER LOT: 925711) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6). ON 12 JUNE 2026, SAMPLE ID 227643 WAS TESTED IN PANTHER WORKLIST ID 1010910581-20260612-25 AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE / NEISSERIA GONORRHOEAE (GC) NEGATIVE RESULT. THE SAME SAMPLE (ID 227643) WAS RETESTED ON 14 JUNE 2026 ON THE SAME PANTHER INSTRUMENT (WORKLIST ID 1010910581-20260614-13) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE/ NEISSERIA GONORRHOEAE (GC) POSITIVE 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.