Events

Recall of N Protein Standard SL and N/T Protein Controls SL

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Siemens Healthcare Diagnostics Inc.

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
    21465
  • Event Initiated Date
    2017-05-24
  • 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: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Reason
    The manufacturer has confirmed a negative bias of approximately -20% for results obtained with n antiserum to human ceruloplasmin when calibrating with specific lots of n/t protein standard sl. n/t protein controls sl for ceruloplasmin are similarly biased. n antiserum to human ceruloplasmin works as intended. a deviation in the value assignment of the affected standards and controls is leading to a lower result compared to correctly assigned standards.
  • Action
    Manufacturer to issue advice regarding use

Device

N Protein Standard SL and N/T Protein Controls SL

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    NZMMDSA