APTIMA COMBO 2 ASSAY
Received Jun 20, 2025 · Event occurred Jun 16, 2025
Report 2024800-2025-00037 · MDR key 22302360
Device
Generic name
Dna-reagents, Neisseria
Manufacturer
Hologic, Inc.Catalog number
302661
Lot number
917189 & 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
NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF THE WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. 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 RECEIVING DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE ID # (B)(6) WAS INITIALLY TESTED IN AC2 WL-010146-20250614-14 USING AC2 MASTER LOT 917189 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT POSITIVE & GC POSITIVE. THE SAME SAMPLE WAS RETESTED ON(B)(6) 2025 IN AC2 WL-010823-20250616-19 USING AC2 MASTER LOT 917920 ON PANTHER PLUS INSTRUMENT SN (B)(6) AND RESULTED CT NEGATIVE & GC NEGATIVE. CUSTOMER REPORTED THE RETESTED CT NEGATIVE & GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. PER APTIMA COMBO 2 ASSAY PACKAGE INSERT ¿THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED¿.