Events

Recall of RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 tests

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-00855-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00855-1
  • 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
    During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the rapidpoint 500 measurement cartridge causing a negative bias on both qc and patient samples.This issue causes a varying negative bias across the measurement range, with the bias increasing with increasing sodium concentrations. taking into account the magnitude of the bias near the reference interval, this issue is not expected to cause clinically significant changes to patient treatment decisions for hypernatremia.
  • Action
    Siemens is notifying laboratories of the error and that the review of previously generated results is at the discretion of the laboratory. Laboratories are given the option to return the affected products. This action has been closed-out on 07/09/2016.

Device

RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic m...
  • Model / Serial
    RAPIDPoint 500 Measurement Cartridges used on the RAPIDPoint 500 System. An in vitro diagnostic medical device (IVD) RAPIDPoint 500 Measurement Cartridge Lactate - 750, 400, 250 and 100 testsSerial Numbers affected: 2517102517 through 2519000012.Please note: Cartridges within the affected serial number range that have a green dot on the box and/or the cartridge are not affected.ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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