Events

Recall of N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).

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-2017-RN-00452-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00452-1
  • 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 observed lower values for carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to former lots. cdt results in absolute concentrations are influenced by the patient’s total transferrin levels and therefore results are reported as ratio of cdt to total transferrin, called %cdt. as the transferrin determination with n antiserum to human transferrin is not affected, the lower cdt result leads to calculated %cdt values that show a negative bias of approximately 10 to 15% compared to former lots. this could result in a shift of weak positive patient samples into the reference range of 1.19 – 2.47 %cdt which was derived from a study population of healthy adults. it is not expected that samples from patients with chronic heavy alcohol consumption will be misclassified.
  • Action
    Siemens is advising users to discontinue use of and discard the affected lots. Replacement stock will be provided by Siemens. It is recommended that users review the customer letter with the laboratory Medical Director.

Device

N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    N Latex Carbohydrate-deficient Transferrin (CDT). An in vitro diagnostic medical device (IVD).Catalogue Number: OPCS035Siemens Material Number: 10445996Lot Numbers: 45834 & 45987 (Expiry 3 Jun 2017); 46116, 46244, 46388 & 46568 (Expiry 10 Oct 2017)ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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