APTIMA COMBO 2 ASSAY
Received Jun 20, 2025 · Event occurred Jun 2, 2025
Report 2024800-2025-00035 · MDR key 22299397
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
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 917189 ON THEIR PANTHER INSTRUMENTS. SAMPLE ID (B)(6) INITIALLY RESULTED DUAL POSITIVE (CT POSITIVE, GC POSITIVE) ON PANTHER PLUS INSTRUMENT (SERIAL NUMBER (B)(6) UNDER WORKLIST (B)(6). THE SAME SPECIMEN WAS RETESTED AND RESULTED DUAL NEGATIVE (CT NEGATIVE, GC NEGATIVE) ON WORKLIST (B)(6) ON PANTHER INSTRUMENT (SERIAL NUMBER (B)(6). THE SPECIMEN WAS RETESTED AGAIN ON A DIFFERENT PANTHER INSTRUMENT (SERIAL NUMBER (B)(6) AND RESULTED DUAL NEGATIVE (CT NEGATIVE, GC NEGATIVE) ON WL (B)(6). CUSTOMER NOTED THAT PER LAB POLICY, THE DUAL POSITIVE RESULT WAS NOT REPORTED OUT, AND THE DUAL NEGATIVE RESULT WILL BE REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.
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.