Events

Recall of Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). 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-01237-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01237-1
  • 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 certain lots of aqc have been incorrectly value assigned resulting in a +8 g/l bias for level 1 thb on rapidpoint 400/405/500 systems. some users are reporting higher than expected results for this aqc level. since the mis-assigned value is within the allowable range, there are no error flags. customers who use rilibak ranges or have tightened the aqc ranges may see a failed aqc error code.
  • Action
    Siemens is advising users that if the Quality Control values are recovering within range, users may continue to use the current stock of AQC cartridges that they have from these lots. For users experiencing tHb running high for AQC Level 1, a suggested workaround is to reset the target tHb value for Level 1 as 188 g/L, while using the impacted cartridges. Siemens is recommending users review the letter with their Medical Director.

Device

Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro di...
  • Model / Serial
    Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Lot Numbers: AQC/19516, AQC/19616, AQC/20816, AQC/20916, AQC/21016, AQC/21416, AQC/21516ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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