APTIMA COMBO 2 ASSAY
Received Jul 1, 2025 · Event occurred Jun 6, 2025
Report 2024800-2025-00040 · MDR key 22373360
Device
Generic name
Dna-reagents, Neisseria
Manufacturer
Hologic, Inc.Model number
COMMONCatalog number
302661
Lot number
917920
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 TECHNICAL SUPPORT REVIEWED ALL CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT CHEMISTRY ISSUES. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THE ISSUE WAS LIKELY DUE TO EITHER LOW TARGET SAMPLES 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 JUNE 6, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY WERE QUESTIONING RESULTS OF SAMPLE ID (B)(6) USING THE APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 917920. ON (B)(6) 2025, THE CUSTOMER RECEIVED A DUAL POSITIVE RESULT (CT POSITIVE / GC POSITIVE) ON PANTHER SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(4). THE SAMPLE WAS RETESTED ON (B)(6) 2025 AND HAD A DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) ON PANTHER SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(4). CUSTOMER REPORTED THE SAME SAMPLE TUBE WAS TESTED BOTH TIMES AND THE DUAL NEGATIVE RESULT (CT NEGATIVE / GC NEGATIVE) WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.