Events

Recall of ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device.

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-2015-RN-00062-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00062-1
  • 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 determined that incorrect calibrator lot values were assigned for advia chemistry systems drug calibrator i, lot 3jd018, for the advia chemistry systems phenytoin 2 (phny_2) and phenobarbital 2 (phnb_2) assays. this issue was determined to be the result of calibrator value miscalculation. calibrator lot 3jd018 has now been value assigned to align with the correct calibrator values.This poses a risk of an incorrect value of -10% being assigned for phenytoin testing and 3% for phenobarbital.Siemens considers these differences are negligible and would not be considered substantially relevant to impact clinical care in practice.
  • Action
    Calibrator value reassignments are being provided in the Customer Letter for users to correct the problem. This action has been closed-out on 14/02/2017.

Device

ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro...
  • Model / Serial
    ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. Lot Number: 3JD018Expiration Date: April 2015Siemens Material Number: 10376770ARTG Number: 175699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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