APTIMA COMBO 2 ASSAY
Received Jun 17, 2025 · Event occurred May 21, 2025
Report 2024800-2025-00034 · MDR key 22240977
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
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. 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 THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) MASTER LOT 915709 ON THE PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6). SAMPLE ID (B)(6) INITIALLY RESULTED CT POSITIVE AND GC EQUIVOCAL UNDER (B)(6). THE SAME SAMPLE WAS RETESTED AND RESULTED CT NEGATIVE AND GC NEGATIVE ON (B)(6). CUSTOMER CONFIRMED THAT 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 EVENT.