Events

Recall of 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
    21692
  • Event Initiated Date
    2017-07-17
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    During an internal assessment the manufacturer found that application sheets provided by microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use, when not used on manufacturer approved analyzers, is inadequate. in addition microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.
  • Action
    Manufacturer to issue advice regarding use

Device

Microgenics Application Sheets
  • Model / Serial
    Model: , Affected: Various Microgenics Appliction Sheets, All Lots
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation