Events

Recall of Remel Xpect Clostridium difficile Toxin A/B

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
    13442
  • Event Initiated Date
    2012-09-03
  • 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: Oxoid NZ, 3 Atlas Place, Mairangi Bay, AUCKLAND 1333
  • Reason
    The manufacturer has advised that a technical investigation has confirmed that some units of the reagents in these lots of remel xpect® clostridium difficile toxin a/b, r24650/r24640 may contain microbial contamination that could impact assay procedure and/or performance.
  • Action
    Product to be destroyed

Device

Remel Xpect Clostridium difficile Toxin A/B

Manufacturer

Thermo Fisher Scientific Microbiology Basingstoke