APTIMA COMBO 2 ASSAY
Received Jun 3, 2026 · Event occurred May 21, 2026
Report 2024800-2026-00027 · MDR key 25384549
Device
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE PANTHER LOG FILES AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. THE DISCREPANT RESULT APPEARED TO BE SAMPLE RELATED, POSSIBLY DUE TO LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.
Description of Event or Problem
ON (B)(6) 2026, CUSTOMER REPORTED TO HOLOGIC INCONSISTENT SAMPLE RESULTS WHILE PERFORMING VALIDATION TESTING WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY ON THEIR PANTHER FUSION PLUS INSTRUMENTS. CUSTOMER CONFIRMED THAT THE INITIAL TEST RESULTS WERE REPORTED OUT. CUSTOMER PROVIDED LOGS. ON (B)(6) 2026, SAMPLE ID (SID) (B)(6) WAS INITIALLY TESTED ON CT/GC WORKLIST (B)(4) (ML 926168) ON PANTHER INSTRUMENT (SN (B)(6) AND RESULTED CT POSITIVE/GC NEGATIVE. ON (B)(6) 2026, CUSTOMER RETESTED THE SAME SAMPLE (SID) (B)(6) ON CT/GC WORKLIST (B)(4) (ML 928004) ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6), AND THE VALIDATION TEST RESULTED CT POSITIVE/GC POSITIVE. 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. INSTRUMENT WAS OPERATIONAL, AND NO FURTHER ISSUES WERE REPORTED.