Events

Recall of ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)

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-00878-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00878-1
  • 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 received complaints of failed calibrations on the advia centaur® cp system when using bnp kit lots ending in 172. siemens has confirmed that the failed calibration is due to an error on the advia centaur cp master curve card. the master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the advia centaur cp. an invalid calibration status will prevent bnp results from being generated and may delay the time to result for bnp. if the calibration is successful, the results will be valid and there is no risk to health.
  • Action
    Siemens is advising that if a successful calibration is achieved with BNP kit lots ending in 172 and quality control results are in range, you can continue to report patient results. If unable to obtain a successful calibration on the ADVIA Centaur CP with BNP kit lots ending in 172, please switch to an alternate lot of BNP. This action has been closed-out on 31/08/2016.

Device

ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)
  • Model / Serial
    ADVIA Centaur CP – BNPCatalogue Numbers: 02816138 (100 tests) and 02816634 (500 tests)Siemens Material Numbers (SMN): 10309044 and 10309045 Lot Numbers: lots ending in 172 (Expiration date: 17 April 2015)ARTG Number: 175075
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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