APTIMA COMBO 2 ASSAY
Received Sep 24, 2025 · Event occurred Sep 22, 2025
Report 2024800-2025-00062 · MDR key 23138036
Device
Product problems
- Off-Label Use
- Off-Label Use
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 A DISCREPANT RESULT FOR SAMPLE ID (SID) (B)(6) WHILE USING APTIMA COMBO 2 ASSAY MASTER LOT 922686 ON THEIR PANTHER INSTRUMENT. ON (B)(6) 2025, CUSTOMER INITIALLY TESTED SID (B)(6) ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON WORKLIST (WL) (B)(4) AND RECEIVED A DUAL CT POSITIVE, GC POSITIVE RESULT. PER CUSTOMER LAB POLICY, A SAMPLE IS RETESTED IF THERE IS A DUAL CT POSITIVE, GC POSITIVE RESULT. ON (B)(6) 2025, CUSTOMER RETESTED THE SID (B)(6) ON (B)(4) USING APTIMA COMBO 2 ASSAY MASTER LOT 924264 ON A DIFFERENT PANTHER INSTRUMENT SN (B)(6) AND RECEIVED A DUAL CT NEGATIVE, GC NEGATIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT NEGATIVE, GC NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES; THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS SAMPLE RELATED. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.