Events

Recall of ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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
    RC-2016-RN-00068-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00068-1
  • 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 is conducting a correction for the certain estradiol products. it has been confirmed that the drug fulvestrant (faslodex) may cause falsely elevated estradiol results in the assays listed, which could lead the clinician to misinterpret the patient as pre-menopausal possibly leading to altered or discontinued use of the potential beneficial drug fulvestrant.The risk to health applies to all patients being treated with the drug fulvestrant.
  • Action
    Siemens’ Estradiol assays may continue to be used to report results for patients not on Fulvestrant therapy; these assays should not be used for patients being treated with Fulvestrant. For patients being treated with Fulvestrant, an alternate method such as LC-MS which is not expected to show cross reactivity to Fulvestrant should be used to measure Estradiol concentrations.

Device

ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays
  • Model / Serial
    ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol AssaysADVIA Centaur Enhanced EstradiolCatalogue # and SMN: 10490889, 10491445, 10697757Dimension Vista LOCI EstradiolCat # K6463SMN: 10489099IMMULITE/ IMMULITE 1000 EstradiolCat #: LKE21, LKE21(D)SMN: 10381132, 10702832IMMULITE 2000 EstradiolCat #: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)SMN:10381178, 10702833, 10381177, 10702834All lots affectedARTG # 175698, 180109 and 179720
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA