MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD ONCLARITY¿ HPV ASSAY REAGENT PACK US; HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD

Catalog Number	441990
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device lot: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of bd onclarity¿ hpv assay reagent pack, a discrepant patient result was obtained.Initial testing gave hpv positive result.Provider recollected sample and tested again, and result was negative.Both initial and recollected sample were retested, and both were negative.There was no report of patient impact.

• Brand Name: BD ONCLARITY¿ HPV ASSAY REAGENT PACK US
• Common Device Name: HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 25510765
• Report Number: 1119779-2026-00949
• Device Sequence Number: 10524942
• Product Code: MAQ
• UDI-Device Identifier: 00382904419905
• UDI-Public: (01)00382904419905(17)261219(10)5344906
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160037
• 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,Followup
• Report Date (Section B): 06/22/2026

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: 441990
• Device Lot Number: 5344906
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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