Events

Recall of AllSet = Gold SSP

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 Australia Pty 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
    21610
  • Event Initiated Date
    2017-07-03
  • 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: Bio-Strategy Ltd, 22a William Pickering Drive, North Harbour, Albany, Auckland 0751
  • Reason
    The manufacturer is aware of the allset+ gold ssp kits. the primers pm074d and c15-02a should be negative for the following alleles: :, b*07:219, b*57:02:01, , b*57:02:02, , b*57:03:02, , b*57:07, b*57:09, b*57:12, b*57:17, b*57:28n, b*57:39, b*57:42, b*57:46, b*57:57, b*57:63, b*57:66, b*57:70, b*57:80, b*57:82, b*58:08:01, b*58:08:02, b*58:20, b*58:27, b*58:28:01, b*58:28:02, b*58:65, and b*58:73 during analysis. the lot specific user documents and software uch files contain the incorrect allele specificity information for these two primer mixes.
  • Action
    Manufacturer to issue advice regarding use

Device

AllSet = Gold SSP

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd