Events

Recall of RAPIDPoint 500 Measurement Cartridges. 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 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-2014-RN-00601-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00601-1
  • 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 received several reports from customers of one or more electrolyte parameters (e.G., na+, ca++, k+, cl-) reporting a “-----?” error code when aqc, qc, or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited, the issue is usually seen during level 1 qc /aqc, level 1 cvm, and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples.
  • Action
    Customers are advised that the following steps can be taken to mitigate the issue: - Install a RAPIDPoint 500 Measurement Cartridge or - Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge or - Use an alternative system to obtain the electrolyte values. Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem.

Device

RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)Part numbers: 10844813, 10491447, 10491448 & 10491449Serial Numbers: 2334500011 to 2412705915ARTG number: 176642
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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