MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, Inc. (BD DIAGNOSTICS) BD COR CTGCTV2 US; Multiple-type sexually transmitted pathogen nucleic acid IVD kit

Catalog Number	445435
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd cor ctgctv2 us, a false positive neisseria gonorrhoeae (gc) patient result was obtained.First run on bd max vaginal panel and bd cor ctgctv2 us was gc positive.Patient requested repeat testing.Second run on bd cor ctgctv2 us was gc negative.A separate sample from same patient was also run on thermofisher openarray¿ and was negative for gc.There was no report of patient impact.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD COR CTGCTV2 US
• Common Device Name: Multiple-type sexually transmitted pathogen nucleic acid IVD kit
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, Inc. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, Inc. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; +1(410)316-4000
• MDR Report Key: 50932322
• Report Number: 3007420875-2026-00185
• Device Sequence Number: 9508992
• Product Code: QEP
• UDI-Device Identifier: 00382904454357
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K243343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 445435
• Device Lot Number: 6005442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown