Events

Recall of ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. 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-00310-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00310-1
  • 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 platelet clump flags (plt-clm) are generated in the perox channel of the advia 120/2120/2120i haematology system while running cbc/diff (complete blood count / differential) whole blood samples with diff timepac perox 1 reagent lot # 57211, in samples without platelet clumps. the accuracy of the platelet results are not impacted when the perox 1 reagent (lot 57211) is used on the system and a plt-clm flag is generated due to this issue. additionally, platelet results are reported from the red blood cell/platelet (rbc/plt) channel and not measured in the perox channel where platelet clumps are detected. however, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.
  • Action
    Siemens is requesting customers discontinue use of and discard the entire lot of ADVIA 120/2120/2120i DIFF TIMEPAC products listed in Table 1 of the Customer Letter. Complete and return the Response Form attached to the Customer Letter by Friday 20th April 2018 as confirmation that you have received and understood this Recall Action.

Device

ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Med...
  • Model / Serial
    ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)Catalogue Number: SMN 10312270Lot Numbers: 74264,73839, 57211Expiration Date: 31/7/19 ARTG Number: 184207(Siemens Healthcare - Haematology full blood count IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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