Events

Recall of IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
    RC-2015-RN-00131-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00131-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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.The bias in quality control values is the result of the introduction of a new lot of the bead coat antibody (murine monoclonal anti-ca 19-9 antibody) in kit lot 312. 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
    Siemens is advising that patients may need to be re-base lined with kit lot 312 or higher. A look back over previously generated results should be discussed with the treating physician.

Device

IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias
  • Model / Serial
    IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive BiasCatalogue number: L2KGI2Siemens Material Number: 10380988Lot numbers: 312 and 313ARTG number: 180780
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA