Events

Recall of Innovance D-Dimer assay run on Sysmex CS Systems. 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-00112-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00112-1
  • 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 that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions:- the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution; and- the raw signal that is generated from the reanalysis is below the limit of blank (lob) of the method.Under such conditions the low reanalysis raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value is corrected by the dilution factor and can then be incorrectly calculated from the calibration curve as a falsely low result.
  • Action
    Siemens is advising customers that the threshold for “Min Range” of the extrapolation needs to be changed within the Innovance D-Dimer assay setting on the Sysmex system as follows: - In the CS software, Select “Menu” - Select “Settings” - Select “Assay Group Settings” - Select “Innovance D-dimer” assay - Double click assay parameter “INN DDi” - Under the “Calculation Method” tab, change the current “Extrapolation” threshold for the “Min” extrapolation range from 0.01 to the new threshold of 1.00 - Select “Save” and restart CS-System software After the restart, the system will work with the new setting. Siemens is also recommending that laboratories discuss the customer letter with their Medical Director and consider the need for a look-back of previously generated results that may be affected by this issue.

Device

Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).Sysmex CS-2000iSiemens Material Number: 10488064Sysmex CS-2100iSiemens Material Number: 10488062Sysmex CS-2500Siemens Material Number: 11239235Sysmex CS-5100 Siemens Material Number: 10709128ARTG Number: 179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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