Events

Recall of Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. 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 Ltd Diagnostics Division.

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-2012-RN-01168-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01168-1
  • 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
    The automatic quality control (aqc) cartridge can be difficult to remove from the system and will occasionally post a d33:2 valve error and fail to eject from the instrument. the manufacturer advises that the error is generated only during a failed ejection of the aqc cartridge. the issue appears to coincide with the recent introduction of the new return spring design for the aqc cartridge.
  • Action
    Siemens is providing work around instructions for users to implement.

Device

Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 S...
  • Model / Serial
    Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. In vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Serial Number: 1335866035 to 1350036305ARTG Number: 185171An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA