Events

Recall of Roche PreciControl Varia

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

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
    20953
  • Event Initiated Date
    2016-12-16
  • 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
    During routine quality control checks it was observed that the barcode and value sheet of precicontrol varia lot 189285-01 contain an wrong target value for pth on elecsys 2010 cobas e 411, for control level 2. the currently present value of 17.4 pmol/l (164 pg/ml) is incorrect.
  • Action
    Manufacturer to issue advice regarding use

Device

Roche PreciControl Varia
  • Model / Serial
    Model: , Affected: PreciControl Varia Lot number: 189285-01, Elecsys PTH Assay Lot numbers: 143251 and 185000
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH