Events

Recall of Eiken OC-Sensor reagents and controls

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Eiken Chemical Co. Ltd..

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
    21964
  • Event Initiated Date
    2017-09-13
  • 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: Prohealth Asia Pacific Limited, Level 3, 27 Bath St, Parnell, Auckland 1052
  • Reason
    The manufacturer has made a change to the product ifu. the product ifu will detail more information on temperature stability and an increased usability.The ifu will extend its range of use from 7 days to 14 days.
  • Action
    Instructions for use to be updated

Device

Eiken OC-Sensor reagents and controls

Manufacturer

Eiken Chemical Co. Ltd.