APTIMA COMBO 2 ASSAY
Received Oct 30, 2025 · Event occurred Oct 7, 2025
Report 2024800-2025-00067 · MDR key 23426132
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 REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. CUSTOMER NOTED THAT THEY RAN ENVIRONMENTAL SWABS AND RECEIVED NO INDICATION OF CONTAMINATION. 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 TO HOLOGIC THAT THEY RECEIVED DISCREPANT CHLAMYDIA TRACHOMATIS (CT) RESULTS ON THREE SAMPLES WHILE USING THE APTIMA COMBO 2 ASSAY (AC2, ML (B)(6)) ON THEIR PANTHER FUSION PLUS INSTRUMENT (SN (B)(6)). ON (B)(6) 2025, CUSTOMER TESTED THREE SAMPLE IDS (SIDS) (B)(6) ON PANTHER FUSION PLUS WORKLIST (WL) (B)(4) AND RECEIVED CT POSITIVE, CT POSITIVE, AND CT NEGATIVE RESULTS, RESPECTIVELY. CUSTOMER REPORTED OUT THESE SAMPLE RESULTS. CUSTOMER SUSPECTED POSSIBLE CONTAMINATION DUE TO HARDWARE ERRORS IN THE DAY FOLLOWING THE INITIAL TEST AND DECIDED TO RETEST THESE SAMPLES ON A DIFFERENT PANTHER INSTRUMENT (SN (B)(6)) UNDER WL (B)(4). UPON RETEST, CUSTOMER RECEIVED CT NEGATIVE, CT NEGATIVE, AND CT POSITIVE RESULTS FOR THESE SAMPLES SID (B)(6), RESPECTIVELY. CUSTOMER AMENDED THE INITIAL RESULTS WITH THE RETEST RESULTS AND REPORTED THEM OUT. CUSTOMER DID NOT HAVE ADDITIONAL PATIENT INFORMATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.