Events

Recall of The Binding Site SPAPLUS Analyser

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
    16207
  • Event Initiated Date
    2014-02-12
  • 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 it has received reports of the "prog error (overflow) det comm" error message on spaplus analysers with the 'c' suffix in the serial number. when the error occurs, analysis will stop and a full shutdown is required to restart testing. in addition to this, it causes results to be lost and the sample/reagents to be wasted.
  • Action
    Product to be modified

Device

The Binding Site SPAPLUS Analyser

Manufacturer

The Binding Site Group Ltd