Events

Recall of ThermoFisher Oxoid Nitrocefin

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Thermo Fisher Scientific Microbiology Basingstoke.

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
    19928
  • Event Initiated Date
    2016-03-22
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Reason
    A technical investigation has confirmed that individual bottles of oxoid nitrocefin (+ reconstitution fluid), lot 1717357 may produce weak beta-lactamase reactions. not all of the lot is affected; however, continued use may result in delayed or false negative reporting.
  • Action
    Product to be destroyed

Device

ThermoFisher Oxoid Nitrocefin

Manufacturer

Thermo Fisher Scientific Microbiology Basingstoke