Events

Recall of Hand-held Barcode Scanner used with VITROS clinical chemistry 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-00033-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00033-1
  • 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 (ocd) has received a report that when using a hand-held barcode scanner in combination with use of the batch programming option for programming samples, the scanner unexpectedly skips sample cup positions. for example, a sample tube barcode is scanned for the cup 1 position, the cursor in the batch programming screen skips the cup 2 position and advances to the cup 3 position. if this anomaly occurs, there is a potential for mis-associated results.
  • Action
    OCD is providing instructions on the reprogramming of the barcode scanner. Once the barcode scanner is reprogrammed the issue will not occur. This action has been closed-out on 15/07/2016

Device

Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic med...
  • Model / Serial
    Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD).Product Code: 6844210ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics