Events

Recall of Epiclone™ Anti M

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Seqirus 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
    22317
  • Event Initiated Date
    2017-11-27
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Reason
    1 lot of epiclone™ anti m may cause false positive reactions against m negative phenotypes when used with cat cards. (note that this lot is able to identify m positive phenotypes when used with cat cards and remains suitable for use by the tube method.).
  • Action
    Manufacturer to issue advice regarding use

Device

Epiclone™ Anti M
  • Model / Serial
    Model: , Affected: Lot number 009817601, Expiry 11/06/2019
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd