Events

Recall of RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). 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-2016-RN-01187-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01187-1
  • 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 has confirmed an error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge for certain cartridge serial numbers. the maximum % bias observed due to error ranges from -2.3% at 65mmol/l to +5.9% at 132 mmol/l. at extremely high chloride values (>122 mmol/l), a positive bias of 5% or greater may be observed. there have not been any reports of injury due to this issue. all the other electrolytes (na+, k+, ca++) and blood gas parameters are correctly assigned in these measurement cartridges.
  • Action
    Siemens is advising users to review the chloride calibrators bias information provided in the recall for product correction letter with their Medical Director.

Device

RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic me...
  • Model / Serial
    RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).RAPIDPoint 400 Measurement Cartridge Siemens Material Numbers (SMN): 10329756, 10341161RAPIDPoint 405 Measurement CartridgeSiemens Material Numbers (SMN): 10844812, 10283222, 10313971, 10310469Cartridge Serial Numbers: 2610900214 through 2621001325ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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