Events

Recall of RemelTM BactiStaph Latex Kits R21144,

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
    22274
  • Event Initiated Date
    2017-11-20
  • 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
    The manufacturer has received complaints of positive control failure which triggered a technical investigation which confirmed the positive control contained in the referenced products, bactistaph latex kits r21143/r21144, lots 104809/104807, may be non-reactive. the latex reagent in the kit performs as specified.
  • Action
    Product to be destroyed

Device

RemelTM BactiStaph Latex Kits R21144,

Manufacturer

Thermo Fisher Scientific Microbiology Basingstoke