APTIMA COMBO 2 ASSAY
Received Feb 4, 2026 · Event occurred Jan 6, 2026
Report 2024800-2026-00004 · MDR key 24257644
Device
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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. WHILE THE CAUSE OF THE OBSERVED DISCREPANT RESULTS IS UNKNOWN, IT IS POSSIBLE THE STRING OF NINE DISCREPANT RESULTS WAS DUE TO KIT OR ENVIRONMENTAL CONTAMINATION IN THE LAB. HOLOGIC REVIEW DID NOT SHOW INDICATION OF INSTRUMENT CONTAMINATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE. H3 OTHER TEXT: OTHER.
Description of Event or Problem
ON JANUARY 6, 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON NINE SAMPLES WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT ((B)(6)). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED THE NINE SAMPLES ON AC2 WORKLIST (WL) (B)(4) AND RECEIVED A CT POSITIVE/ GC POSITIVE RESULT ON SAMPLE ID (B)(6) AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SID¿S; (B)(6). CUSTOMER SUSPECTED ENVIRONMENTAL CONTAMINATION AND RE-RAN THE SAMPLES IN QUESTION USING A NEWLY RECONSTITUTED ASSAY KIT. CUSTOMER PERFORMED A RETEST OF ALL NINE SAMPLES ON WORKLIST IDS (WL) (B)(4) AND (WL) (B)(4) AND RECEIVED A CT NEGATIVE/GC POSITIVE RESULT ON SAMPLE ID ((B)(6)) AND CT POSITIVE/GC NEGATIVE RESULTS ON SID; (B)(6). CUSTOMER REPORTED OUT THE RESULTS FROM THE INITIAL WL (B)(4). CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.