Events

Recall of Ortho Clinical Diagnostics BioVue System Cassettes

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 European Support Centre.

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
    15059
  • Event Initiated Date
    2013-08-08
  • 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
    Ortho clinical diagnostics (ocd) has identified isolated occurrences of improperly positioned cassette labels for the products specified. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
  • Action
    Product to be exchanged

Device

Ortho Clinical Diagnostics BioVue System Cassettes
  • Model / Serial
    Model: BioVue ABD confirmation Cassette, VioVue Rh/K Cassette, BioVue ABO-DD Grouping Cassette, BioVue ABO-Rh Grouping Cassette, BioVue Poly/Neutral Cassette, Affected: Lots: 6904485 and 707135
  • Manufacturer
    Ortho-Clinical Diagnostics European Support Centre

Manufacturer

Ortho-Clinical Diagnostics European Support Centre