APTIMA COMBO 2 ASSAY
Received Apr 13, 2026 · Event occurred Apr 1, 2026
Report 2024800-2026-00019 · MDR key 24860717
Device
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- 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. THE ISSUE APPEARED TO BE SAMPLE RELATED, MOST LIKELY DUE TO LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY PATIENT TREATMENT OR ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.
Description of Event or Problem
ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED 15 SAMPLES ON AC2 WORKLIST (WL) (B)(6) AND RECEIVED A CT POSITIVE/GC NEGATIVE RESULT ON SEVEN SAMPLES, AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SAMPLES. CUSTOMER WAS CONCERNED ABOUT A CLUSTER OF SIX CT POSITIVE/GC NEGATIVE SAMPLES AND RE-TESTED ALL 15 SAMPLES USING THE SAME AC2 ASSAY KIT. THE REPEAT(B)(6) CONTAINED DISCREPANT RESULTS ON FIVE SAMPLES: SID (B)(6) RESULTED CT NEGATIVE/GC NEGATIVE (ORIGINALLY CT POSITIVE/GC NEGATIVE) AND SID (B)(6) RESULTED CT POSITIVE/GC NEGATIVE (ORIGINALLY CT NEGATIVE/GC NEGATIVE). CUSTOMER REPORTED THE CT NEGATIVE/GC NEGATIVE RESULTS FROM THE REPEAT (B)(6) CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.