Events

Recall of RAPIDQC Complete Solution Level 3. 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-00470-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00470-1
  • 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 identified that the ph parameter may recover low within range or lower than expected with the affected lots of level 3 rapidqc complete product on both the rapidpoint and the rapidlab blood gas systems. the issue identified represents a negligible risk to patients and does not pose any health or safety risk to operators.
  • Action
    Siemens is advising users that if the QC values are recovering within range, the lots can continue to be used. If the affected lots are not recovering within range, the lots will be replaced with unaffected stock.

Device

RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    RAPIDQC Complete Solution Level 3. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10309927Lot Numbers: 363403, 363404, 363501ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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