Events

Recall of Phada AB EliA CCP Positive Control 250

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
    20140
  • Event Initiated Date
    2016-05-06
  • 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: Thermo Fisher Scientific New Zealand Ltd, 244 Bush Road, Albany, AUCKLAND
  • Reason
    When using the phada elia ccp well (14-5515-01) in combination with elia igg conjugate, anti-ccp-signals can be elevated for specific conjugate lots., the positive bias of the elia ccp test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.
  • Action
    Instructions for use to be updated

Device

Phada AB EliA CCP Positive Control 250
  • Model / Serial
    Model: 83-1-35-01, Affected: Lot Nos: C9VBF C9VBH and C9VBK (vials) HG56 HJPS HM8Z and J5N5 (Kits)
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479