Events

Recall of VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. 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 Australia Pty Ltd.

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-2017-RN-00361-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00361-1
  • 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
    It has been confirmed that some lots of vitros nt-probnp reagent packs exhibited the potential for an increased frequency of calibration failures, with an unexpected increase in signal for the level 1 calibrator, potentially causing a failure of the calibration parameters. preliminary testing has indicated that the calibration failure is related to a component of the vitros nt-probnp reagent pack and is not associated with the vitros nt-probnp calibrators. please note that investigations have confirmed that the increase in signal does not affect sample results (i.E., quality control or patient samples) within the 28 day calibration cycle.
  • Action
    Ortho Clinical Diagnostics (Ortho) is advising users that they will be sent the revised Master Calibration data to ensure successful future calibrations. In the interim, users are requested to refer to the workaround details contained in their recall notifications. Users (of Lots 1580, 1590 and 1620) who experience this issue and who no longer wish to use the affected products can have the option of having their accounts credited for the product/s discarded.

Device

VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)Unique Device Identifier Number: 10758750002061Product Code: 6502156Lot Numbers: 1570 (exp. 22 Mar 2017), 1580 (exp. 13 Apr 2017), 1590 (exp. 27 Apr 2017) and 1620 (exp. 06 Jul 2017)ARTG Number: 245492
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd