Events

Recall of Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs)

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-2013-RN-00153-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00153-1
  • 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 have confirmed customer complaints of falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent. the inaccurate ezcr results are caused by a reagent interaction that occurs when vapour from phos reagent is absorbed by open wells of the excr flex reagent cartridge. both quality control (qc) samples and patient samples are affected.
  • Action
    If both Enzymatic Creatinine and Phosphorus are tested using the instrument, customers are requested to discontinue the use of one of the tests. Customers with two or more Dimension systems should perform testing of Enzymatic Creatinine and Phosphorus on separate instruments. This action has been closed-out on 12/02/2016.

Device

Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for...
  • Model / Serial
    Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs)PHOS Flex Reagent CartridgeCatalogue Number: DF61Material Number: 10444951EZCR Flex Reagent CartridgeCatalogue Number: DF270BMaterial Number: 10471520ARTG Number: 181686
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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