Events

Recall of N Latex 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-2018-RN-00645-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00645-1
  • 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 a negative bias for the carbohydrate-deficient transferrin (cdt) measurement when using the affected n latex cdt lots in comparison to the hplc method.Cdt results in absolute concentrations may be influenced by patient’s 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 observed effect leads to calculated %cdt values that show a negative bias of approximately 15% compared to the hplc method. 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.
  • Action
    Siemens Healthcare Diagnostics has assigned optimised values to the affected lots of standards and controls included in the kit lots. Those lots of standards and controls can be used with the revised assigned values and acceptance ranges. Siemens is advising users to: · Recalibrate their CDT method with N CDT Standard lots listed in the Customer Letter, using the revised assigned values provided in the communication. · Use the revised assigned values and respective ranges of the N CDT Controls provided in the Customer Letter. · For BN ProSpec and Atellica NEPH 630 customers, a new Lot Data CD as well as new Secure Download Files are expected to be available in June 2018 including the revised CDT target values for N CDT Standard, N CDT Control 1 and N CDT Control 2. · Ensure that the values manually entered according to the Customer Letter are not overwritten by using an older Lota Data CD/Secure Download File afterwards.

Device

N Latex CDT. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    N Latex CDT. An in vitro diagnostic medical device (IVD)Catalogue Number: OPCS03Material Number: 10445996Lot Numbers: 47167, 47168, 47430, 47431, 47433, 47597, 47642, 47727, 47848, 48013, 48014, 48118 & 48169ARTG number: 178153(Siemens Healthcare - Clinical chemistry-specific protein IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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