Events

Recall of Bio-Rad Dengue NS1 Ag Strip Dengue Virus NS1

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    19590
  • Event Initiated Date
    2015-12-21
  • 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-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Reason
    Degrading of sensitivity for dengue ns1 ag strip [ref 70700] for the lot numbers mentioned above. potential consequnce is false negative result.
  • Action
    Product to be destroyed

Device

Bio-Rad Dengue NS1 Ag Strip Dengue Virus NS1
  • Model / Serial
    Model: 70700, Affected: Lot Nos: 5F0130 5H0131 5H1131 and 5H2131
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479