Events

Recall of VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). 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-2016-RN-01376-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01376-1
  • 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 has confirmed that some barcode labels included in some vitros calibrator kit 25, lot 2576 cartons contain an incorrect lot number. the labels indicate lot 2575 instead of the correct lot 2576 for all three calibrator levels. the printed barcode labels are used with the automatic calibration feature when calibrating vitros 4600 or 5600 systems. when the operator attempts to use the affected barcode labels to calibrate vitros dhdl slides, a ‘pzc-006’ condition code occurs, indicating that the calibrator lot is not supported by the assay data disk (add); therefore the calibration is not successful. all labelling on the calibrator vials and the carton is correct. lot 2576 calibrators perform as expected if the operator manually programs the correct lot information for calibration.
  • Action
    Ortho is advising users to inspect the barcode labels provided in VITROS Calibrator Kit 25, Lot 2576, discard affected labels that indicate Lot 2575, and to manually program Lot 2576 when calibrating VITROS dHDL Slides.

Device

VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Che...
  • Model / Serial
    VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).Product Code: 6801896Lot Number: 2576Expiry Date: 02 Sept 2017ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd