Events

Recall of RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas 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 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-00702-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00702-1
  • 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
    There is an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments. due to this error, the recovery of ph for rapidqc complete, level 2, lot number 362303, is elevated. it is also possible that some instruments may, on occasion, recover ph out of range high. however, the published target ranges for all other analytes are unaffected.
  • Action
    Siemens is providing their customers with the correct pH range assignments (in pH and H+ units) and corresponding barcodes for all the Siemens blood gas systems. End users are requested to re-enter the corrected pH target ranges, or rescan these barcodes into the blood gas system to replace the ones in the Expected Values Chart and keep this notice with the control material. Repeat testing of any patient samples is at the discretion of laboratory.

Device

RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in ...
  • Model / Serial
    RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in vitro diagnostic medical device (IVD).Lot Number 362303ARTG Number: 185171
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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