Events

Recall of Various Microgenics Application Sheets

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

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
    21578
  • Event Initiated Date
    2017-06-28
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Reason
    During an internal assessment, it was found that certain application sheets provided by thermo fisher new zealand for expanded use of some assays on analyzers that are not listed in the assay instructions for use are inadequate. specifically, the validation data included in the application sheets for the expanded use of these assays, is inadequate and will not be included in future application sheets. in addition, statements have been added to the application sheets that explain that the parameter settings are not supplier qualified and are to be used for instrument programming guidance only, and that each assay used on a non-microgenics approved analyzer needs to be validated individually by the user.
  • Action
    Instructions for use to be updated

Device

Various Microgenics Application Sheets
  • Model / Serial
    Model: , Affected: Incomplete Instructions for Use for Microgenics Application Sheets
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation