Events

Recall of Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ortho-Clinical Diagnostics Inc.

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
    15144
  • Event Initiated Date
    2013-08-15
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • 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
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

Manufacturer

Ortho-Clinical Diagnostics Inc