Events

Recall of VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). 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-00974-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00974-1
  • 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
    There is a potential for an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9, lot 0954.The increase in u90-382 and 6lu condition codes primarily occurs when using vitros dgxn and phyt slides. vitros acet and crbm slides are not affected. when the u90-382 or 6lu condition code occurs, the vitros system suppresses the result and no result is reported. all numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.
  • Action
    OCD is advising users to discontinue use and discard all remaining inventory of the affect lot. OCD will replace the affected units or provide a suitable credit. The affected lot may still be used until replacement lots are available. This action has been closed-out on 06/09/2016.

Device

VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS System...
  • Model / Serial
    VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).Product code: 8568040Lot Number: 0954Expiry Date: 31 May 2016Unique Device Identifier Number: 10758750005031ARTG number: 245278
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics