Events

Recall of TBS VaccZyme Anti-Haemophilus Influenzae B

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by The Binding Site Group Ltd.

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
    18118
  • Event Initiated Date
    2015-02-19
  • 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: In Vitro Technologies, 26-30 Vestey Drive, Mount Wellington, Panmure, Auckland
  • Reason
    The manufacturer advises that the type iii sample diluents of batches 341738 and 347336 provided in the above kit (lot numbers 341492 and 347294 respectively) may contain microbial growth. the identified contaminant is not present in all diluent vials but has been identified in some, in the form of either white or black matter of an organic appearance.
  • Action
    Manufacturer to issue advice regarding use

Device

TBS VaccZyme Anti-Haemophilus Influenzae B

Manufacturer

The Binding Site Group Ltd