Events

Recall of VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS MicroSlide Calibrator Kit Numbers: 1 - 10 (inc.) & 25

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-01001-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01001-1
  • 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
    An unexpected assay calibration may occur when using calibrator barcode labels supplied with vitros chemistry products calibrator kits for assay targets that are unassigned.
  • Action
    A correction for this issue will be included in the next version of the software. Ortho-Clinical Diagnostics is requesting their customers to not use the calibrator barcode labels for VITROS Calibrator Kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on the VITROS System. This action has been closed-out on 25/08/2016.

Device

VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS M...
  • Model / Serial
    VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS MicroSlide Calibrator Kit Numbers: 1 - 10 (inc.) & 25ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics