Events

Recall of ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). 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-00247-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00247-1
  • 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 providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifu). the current intended use section within in the advia chemistry systems lactate dehydrogenase ifu document contains the following statements which will be removed (given these assays are not validated to monitor for cancer therapy):"advia chemistry ldlp: they may also be used to monitor cancer therapy.Advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy.".
  • Action
    Siemens is advising users to refer to the revised intended use statement in the notification in order to use the assays as defined. Users will be provided with the updated IFU when it becomes available.

Device

ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).ADVIA Chemistry Lactate Dehydrogenase L-PTest Code: LDLPReference Numbers: 07502115 (40 mL) & 03029628 (70 mL)Siemens Material Numbers: 10309501 (40mL) & 10341128 (70 mL)ADVIA Chemistry Lactate Dehydrogenase P-LTest Code: LDPLReference Numbers: 07502999 (40 mL) & 03030863 (70 mL)Siemens Material Numbers: 10309502 (40 mL) & 10341129 (70 mL)All LotsARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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