Events

Recall of VITROS Chemistry Products MicroSlides (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-2013-RN-00773-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00773-1
  • 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
    The vitros microslide cartridge is made up of the cartridge body and an anti-backup platen (abp). the purpose of the abp is to keep the stacks of slides in the correct position for dispensing. ortho clinical diagnostics have received reports associated with abp failing to advance, jamming or failing to stay locked in place within the cartridge. when this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly.
  • Action
    Ortho Clinical is providing users with work around instructions to resolve slide dispense issues. Users are advised to replace the affected unit and contact Ortho Clinical for a replacement if they are unable to resolve a slide dispense issue by repositioning the ABP. This action has been closed-out on 12/02/2016.

Device

VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))
  • Model / Serial
    VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))Multiple catalogue numbers affectedExpiry dates to 22 March, 2015ARTG Number: 25922
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics