Events

Recall of Roche Elecsys Estradiol 11 and 111 Assays

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
    19811
  • Event Initiated Date
    2016-03-01
  • 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
    If the estradiol status of postmenopausal women under treatment with fulvestrant is tested with elecsys estradiol ii or elecsys estradiol iii assays, an interference leading to falsely increased results of estradiol due to the drug may occur. subsequently the incorrect level of estradiol may lead to misinterpretations of the hormone status and the use of fulvestrant may be altered. in addition the efficiency of anti-estrogen treatment might be underestimated. a medical risk for postmenopausal women under fulvestrant treatment cannot be excluded.
  • Action
    Product to be destroyed

Device

Roche Elecsys Estradiol 11 and 111 Assays
  • Model / Serial
    Model: 03000079190 and 06656021190, Affected: all lot numbers
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479