Events

Recall of VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems, Software Versions 3.1 & Below

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-2014-RN-01251-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01251-1
  • 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
    Ortho clinical diagnostics investigation has determined that the software may not properly identify an expired calibration. calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. if the anomaly occurs, a calibration may expire, but the system may not alert the operator and not flag results with a ce sample result code (i.E., calibration expired). the system may unexpectedly generate results even though it is configured to not report results when a calibration has expired the anomaly may potentially occur on any type of assay processed on the systemif an expired calibration occurs for an assay and is not detected by the operator, samples may be processed without a valid calibration. however, quality control fluids would be processed at the next routinely scheduled time period. if quality control results were acceptable, patient results obtained prior to that time would not have been adversely affected.
  • Action
    The resolution to this anomaly will be contained in the next version of software currently under development. Until the new software is installed on the affected VITROS System, users are advised to use the “All Assay Data” option instead of “Load New Lots" when installing Assay Data Diskettes (ADDs) on the system. If any of the calibrations are expired, the system will post PZB-005 condition codes. Perform calibrations prior to using those reagents. Users are also advised to discuss any concerns that may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 12/08/2016.

Device

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Syst...
  • Model / Serial
    VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems, Software Versions 3.1 & BelowSystem Product Codes: 6802783, 6802445, 6802413ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics