APTIMA COMBO 2 ASSAY
Received May 8, 2026 · Event occurred Apr 29, 2026
Report 2024800-2026-00021 · MDR key 25128789
Device
Generic name
Dna-reagents, Neisseria
Manufacturer
Hologic, Inc.Catalog number
902615
Lot number
924056, 926168
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE PANTHER LOG FILES AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. THE DISCREPANT RESULT APPEARED TO BE SAMPLE RELATED, POSSIBLY DUE TO LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.
Description of Event or Problem
ON APRIL 29, 2026, CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS WHILE PERFORMING A LOT-TO-LOT VERIFICATION FOR SAMPLE ID (SID): (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY ON THEIR PANTHER INSTRUMENT WITH SERIAL NUMBER (SN): (B)(6). ON (B)(6) 2026, SID: (B)(6) WAS INITIALLY TESTED ON WORKLIST (WL) (B)(4) (ML 924056) ON PANTHER INSTRUMENT (SN: (B)(6) AND RESULTED CT NEGATIVE/GC POSITIVE. ON (B)(6) 2026, CUSTOMER RETESTED SID: (B)(6) ON WORKLIST (B)(4) (ML 926168) ON PANTHER INSTRUMENT (SN: (B)(6) AND THE SAMPLE RESULTED CT POSITIVE/GC POSITIVE. ACCORDING TO THE CUSTOMER, THE FIRST VALID RESULT WAS REPORTED TO THE PATIENT. 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.