Events

Recall of ADVIA CENTAUR CP SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    20156
  • Event Risk Class
    III
  • Event Initiated Date
    2014-06-26
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 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 only. an invalid calibration status will prevent bnp results from being generated. the master curve card contained in kit lots ending in 172 for the advia centaur and advia centaur xp platforms is not impacted and there is no calibration issue when using bnp kit lots ending in 172 on those systems.

Device

ADVIA CENTAUR CP SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
  • Model / Serial
    Model Catalog: 02816138 (Lot serial: 038172); Model Catalog: 02816634 (Lot serial: 038172)
  • Product Description
    ADVIA CENTAUR CP SYSTEM- B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC