Events

Recall of Roche Elecsys Vitamin D Assay (300 tests)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    22898
  • Event Initiated Date
    2018-04-30
  • 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
    The manufacturer has been informed of a number of reports of performance issues during the implementation of the elecsys vitamin d total ii assay on modular analytics e170, cobas e601 and cobas e 602 systems, as well as rare cases on cobas e 411 and cobas e 801., the issue manifests as: the first result is elevated, either above the upper end of the measuring range (>250 nmol/l) or within the measuring range; and repeats are significantly lower.
  • Action
    Manufacturer to issue advice regarding use

Device

Roche Elecsys Vitamin D Assay (300 tests)

Manufacturer

manufacturer #1479