Events

Recall of ADVIA Chemistry Halogen Lamp

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-2015-RN-01148-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01148-1
  • 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 conducting a recall for product correction for the advia chemistry halogen lamp (smn 10309448) in advia chemistry systems. siemens has identified specific lot numbers of the halogen lamp that may have a defect that could cause it to fail prematurely.The potential exists for a delay in testing if the halogen lamp fails prematurely. results are not impacted as the system will become inoperable when this issue occurs. the risk to health is low. siemens is not recommending a laboratory look back as a result of this issue.
  • Action
    The sponsor Siemens is advising users to inspect unused stock and discard affected units. The sponsor will replace the affected units. If the Halogen lamp currently installed in the system fails approximately 100 hours after installation, customers are to contact the sponsor for a replacement. This action has been closed-out on 24/05/2017.

Device

ADVIA Chemistry Halogen Lamp
  • Model / Serial
    ADVIA Chemistry Halogen LampSiemens Material Number (SMN): 10309448Affected Lot Numbers: J411, J412, J501, J502, J503, J504, J505, J506Affected ADVIA Chemistry Systems:ADVIA 1200SMN: 10309735, 10470358, Legacy Numbers – 094-A001-02, 094-A001-03, 094-A001-04, 094-A001-05, 094-A001-06ADVIA 1800SMN: 10315183, 10322655, 10337372, 10337373, 10337374, 10337375, 10337376ADVIA 2400SMN: 10315769, 10816871, 10816872, 10816873, 10816874, 10816875, 10816876ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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