APTIMA COMBO 2 ASSAY
Received May 8, 2025 · Event occurred Apr 9, 2025
Report 2024800-2025-00016 · MDR key 21987536
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 REPORTED TO HOLOGIC HIGH LEVELS OF POSITIVE RESULTS WHILE USING THE APTIMA COMBO 2 ASSAY (LOT NUMBER: 909770) ON THE PANTHER INSTRUMENT (SERIAL NUMBER: (B)(6)). ON (B)(6) 2025, SAMPLE ID (B)(6) INITIALLY TESTED CT NEGATIVE/GC POSITIVE IN WORKLIST (B)(4). ON (B)(6) 2025, THE SAME SAMPLE WAS RETESTED ON WORKLIST (B)(4) AND RESULTED CT NEGATIVE/GC NEGATIVE. CUSTOMER CONFIRMED THE CT NEGATIVE/GC NEGATIVE RETEST RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT THOROUGHLY REVIEWED CUSTOMER LOGS AND DID NOT IDENTIFY ANY EVIDENCE OF HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT IS LOW GC TARGET IN SAMPLE ID (B)(6). HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.