Events

Recall of ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra

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-2018-RN-00033-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00033-1
  • 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 the following issues:- the advia centaur cp, xp and xpt systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs), if any of the affected bnp or tsh3ul lots are present on the system(s) when performing on-board dilutions; and.- on the advia centaur xpt only, the system becomes inoperable under the following scenario: 1) scanning the master curve card of advia centaur bnp kit lots ending in 193 or higher or advia centaur tsh3-ultra kit lots ending in 301 or higher, and 2) processing a bnp or tsh3ul onboard dilution of a sample. in this case, the system may display an “unknown state” message and requires customer action. when this error occurs, any tests that are in-process would have to be repeated.
  • Action
    Siemens is advising customers who use ALL ADVIA Centaur Systems: - Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected product kit lots are present on the system - Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. For customers using ADVIA Centaur XPT Systems, if users intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, users must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. For customers using ADVIA Centaur CP Systems, if any of the affected BNP kit lots or TSH3UL kit lots have been in use on the system, users must manually track the time that the Multi-Diluent 15 has been in use on board the system.

Device

ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra
  • Model / Serial
    ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-UltraIn vitro diagnostic medical devicesADVIA Centaur BNP (100 tests)Catalogue: 02816138 SMN Number: 10309044 Kit Lot Numbers ending in: 192,193,196 ADVIA Centaur TSH3-Ultra (100 tests) Catalogue: 06491072 SMN Numbers: 10282378 Kit Lot Numbers ending in: 298, 301ADVIA Centaur TSH3-Ultra (500 tests) Catalogue: 06491080 SMN Number: 10282378 Kit Lot Numbers ending in: 298,301ARTG Number 175075
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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