APTIMA COMBO 2 ASSAY
Received Dec 16, 2025 · Event occurred Nov 28, 2025
Report 2024800-2025-00076 · MDR key 23816699
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, A CUSTOMER IN FRANCE REPORTED TO HOLOGIC THAT A DISCREPANT RESULT WAS GENERATED WHILST USING THE AC2 ASSAY (MASTER LOT: 919348) WITH PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)). THE INCIDENT WAS RECORDED UNDER HOLOGIC REFERENCE NUMBER (B)(4). ON (B)(6) 2025, THE SAMPLE ID (B)(6) WAS TESTED IN PANTHER WORKLIST ID (B)(4) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) NEGATIVE /NEISSERIA GONORRHOEA (GC) NEGATIVE RESULT. THE SAME SAMPLE (ID (B)(6)) WAS RETESTED ON (B)(6) 2025 ON THE SAME PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (GC) NEGATIVE RESULT. ON (B)(6) 2025, THE SAME SAMPLE (ID (B)(6)) WAS RETESTED AGAIN, THIS TIME ON ANOTHER PANTHER INSTRUMENT (WORKLIST ID (B)(4)) AND GENERATED A CHLAMYDIA TRACHOMATIS (CT) POSITIVE/NEISSERIA GONORRHOEAE (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 TS REVIEWED THE SYSTEM LOGFILES PROVIDED BY THE CUSTOMER AND PRELIMINARY ANALYSIS INDICATES THAT THE MOST LIKELY EXPLANATION FOR THE DISCREPANT RESULT IS LOW TARGET IN THE SAMPLE, EITHER BECAUSE THE PATIENT IS (LOW) POSITIVE OR BECAUSE THE SAMPLE WAS MISHANDLED/CONTAMINATED. REVIEW OF THE LOGS AND AMPLIFICATION CURVES DID NOT REVEAL ANY ABNORMALITIES SUGGESTIVE OF A HARDWARE OR INSTRUMENT ISSUE.