Events

Recall of OptiView Amplification Kit (250 Test)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    22394
  • Event Initiated Date
    2018-01-11
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Manufacturer has received increased customer complaints reporting leaking and sticking reagent dispensers. these reports are currently focused on horseradish peroxidase (hrp) dispensers (part of the iview, ultraview and optiview detection kits, as well as cintec plus cytology kit) and with hematoxylin ii.The manufacturer has identified the cause of the issue, and is working to correct it and additionally, has mandated specific requirements for slide controls for customers with affected product in inventory.
  • Action
    Manufacturer to issue advice regarding use

Device

OptiView Amplification Kit (250 Test)

Manufacturer

manufacturer #1479