Events

Recall of Ortho-Clinical Diagnostics VITROS Chemistry Products hsCRP Reagent

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
    15748
  • Event Initiated Date
    2013-11-27
  • 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, inc. (ocd) became aware of discrepancies between the default dilution factors entered on the vitros® system from calibration diskettes (cal disk) and assay data disks (add) drv 5740 and below versus our claims support data. the revised default dilution factors are associated with on-board dilutions performed on vitros® system.
  • Action
    Instructions for use to be updated

Device

Ortho-Clinical Diagnostics VITROS Chemistry Products hsCRP Reagent

Manufacturer

Ortho-Clinical Diagnostics Inc