Events

Recall of Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems

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-2013-RN-01249-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01249-1
  • 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 have received reports of condition codes that occurred during the calibration of microwell assays. investigations have determined that the microwell shuttle weight may be uncoated and out of manufacturing specification. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is performed, there is no effect on patient samples. if an uncoated microwell shuttle weight is installed and calibration is not performed, bias results could potentially occur. internal testing has determined that quality control results using an uncoated well weight showed, on average 10% shift from established means within the quality control ranges. ortho clinical investigations has shown there is not likely to be any impact on patient safety, however, if the results are at or near a decision cut off or reference interval, this could potentially move the result into the incorrect result classification.
  • Action
    Ortho Clinical Diagnostics (OCD) is advising users that a service technician will be inspecting all systems to identify if an uncoated MicroWell Shuttle Weight is in use and replace any affected units. If an uncoated MicroWell Shuttle Weight is identified and replaced, all MicroWell assays are required to be recalibrated. This action has been closed-out on 02/02/2016.

Device

Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated...
  • Model / Serial
    Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated SystemsProduct Codes: 6802783, 6802413ARTG Number: 180199An in-vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics