APTIMA COMBO 2 ASSAY
Received Aug 19, 2025 · Event occurred Aug 16, 2025
Report 2024800-2025-00056 · MDR key 22845763
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 TECHNICAL SUPPORT (TS) REVIEWED THE CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT IS POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLE. 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, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 921141 ON PANTHER PLUS INSTRUMENT. ON (B)(6) 2025, SAMPLE SID (B)(6) WAS TESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT POSITIVE / GC POSITIVE RESULT. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT PER APTIMA COMBO 2 ASSAY PACKAGE INSERT, THE FIRST VALID RESULT FOR EACH ANALYTE IS THE RESULT THAT SHOULD BE REPORTED. CUSTOMER NOTED THEY WERE AWARE, BUT PER THEIR LABORATORY PROTOCOL, THEY ARE REQUIRED TO RETEST DUAL POSITIVE SAMPLES WITH RLU < 1900. ON (B)(6) 2025, THE SAME SAMPLE SID (B)(6) WAS RETESTED USING AC2 (B)(4) ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) AND RETURNED A CT NEGATIVE / GC NEGATIVE RESULT. CUSTOMER REPORTED OUT THE CT NEGATIVE / GC NEGATIVE RESULT TO THE PHYSICIAN/PATIENT. CUSTOMER WAS NOT AWARE OF ANY PATIENT TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.