Events

Recall of Roche PreciControl ClinChem Multi 2

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
    19212
  • Event Initiated Date
    2015-10-13
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    Roche has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module., roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary., target values for currently available pccc1 and pccc2 control lots have been adjusted as per the tables given in the customer letter.
  • Action
    Instructions for use to be updated

Device

Roche PreciControl ClinChem Multi 2

Manufacturer

Roche Diagnostics GmbH