Events

Recall of Siemens Immulite GI-MA CA19-9

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 Products Limited.

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
    18129
  • Event Initiated Date
    2015-02-20
  • 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, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    Siemens healthcare diagnostics has confirmed a positive bias with the bio-rad lyphochek® tumor marker plus control and the bio-rad liquichek™ tumor marker control when used with immulite® 2000/immulite® 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313., in addition, a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above., when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml., future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
  • Action
    Instructions for use to be updated

Device

Siemens Immulite GI-MA CA19-9

Manufacturer

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