Events

Recall of VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ortho-Clinical Diagnostics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00427-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00427-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Internal testing by ortho-clinical diagnostics, inc. (ocd) has determined the need for revisions to the low end of the measuring range for the assay. this revision affects the limit of blank (lob), limit of detection (lod), limit of quantification (loq) and reportable measuring range.
  • Action
    Ortho-Clinical Diagnostics, Inc. (OCD) is providing the updated Instructions For Use (IFU) and instructing the customers to implement the revisions on the VITROS System as below: - For VITROS ECi/ECiQ Systems: Scan the Magnetic Lot Card for Lot 1250 & above. - For VITROS 3600, 5600 Systems: Install ADD DRV 5815 & above. - Update the laboratory procedures and Laboratory Information System, as required. The revision to the low end of the Measuring (Reportable) Range may affect the Laboratory Information System. Users are advised to consult with their Information Technology representative to determine the impact at their facility. IFU documents are also available on the Ortho-Clinical Diagnostics, Inc. (OCD) website.

Device

VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Immunodiagnostic Products NT-proBNP Assay. An in-vitro diagnostic medical device (IVD)VITROS NT-proBNP CalibratorsProduct Code: 6802157GTIN: 10758750002078VITROS NT-proBNP Reagent PackProduct Code: 6802156GTIN: 10758750002061
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics