APTIMA COMBO 2 ASSAY
Received Oct 8, 2025 · Event occurred Sep 25, 2025
Report 2024800-2025-00063 · MDR key 23245430
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
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 LOW TARGET IN THE SAMPLE OR SAMPLE MISHANDLING. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.
Description of Event or Problem
ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC A DISCREPANT RESULTS FOR SAMPLE ID (SID) (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY ML 9242340 ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, CUSTOMER INITIALLY TESTED SID (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 DUAL POSITIVE SID (B)(6) ON WL (B)(4) 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.