Events

Recall of Immuno Anti-dsDNA Kit

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
    17925
  • Event Initiated Date
    2015-01-12
  • 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: Immuno Ltd, Level 1, 330 Ti Raukau Drive, East Tamaki, Auckland
  • Reason
    Specific product codes for the anti-dsdna kit (used to test for antibodies to dsdna), were omitted in error from the packaging material. customers have received the correct products, however due to the omission of the product code on the outer box it is not clearly identifiable if they have received the 50 tests version (im77 lot c323026) or 100 tests version (im771 lot c323027). the kits can be differentiated by the lot numbers printed on the outer box. please note that the individual component labelling within the kit has not been affected. the tracer and ammonium sulphate solution lot numbers were omitted for these particular lots of product listed above.
  • Action
    Instructions for use to be updated

Device

Immuno Anti-dsDNA Kit
  • Model / Serial
    Model: Product codes: IM77 (50 tests), IM 771 (100 tests), Affected: Batch Numbers: C323026 (50 tests), C323027 (100 tests)
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479