Events

Recall of Roche Cobas - Homocysteine Enzymatic Assay

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
    20850
  • Event Initiated Date
    2016-11-21
  • 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 Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Reason
    Following customer complaints, internal investigations have confirmed under recovery of qc and patient samples with homocysteine reagent cat no05385415190 lot no 173114 by approximately 10-15% after 7 days exposure to 25oc. correctly stored reagent may show low recovery after 3-4 months.
  • Action
    Product to be exchanged

Device

Roche Cobas - Homocysteine Enzymatic Assay

Manufacturer

Roche Diagnostics GmbH