Events

Recall of Ortho-Clinical Diagnostics VITROS Chemisty Product Mixing Cup Arrays

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
    15767
  • Event Initiated Date
    2013-11-29
  • 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
    Ocd investigations have determined that some vitros® mixing cup arrays may be out of specifications thereby causing an increase in sample metering dilution errors (eae condition codes) when using vitros 250 or 350 chemistry systems.
  • Action
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics VITROS Chemisty Product Mixing Cup Arrays

Manufacturer

Ortho-Clinical Diagnostics Inc