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
    31769
  • Event Risk Class
    III
  • Event Initiated Date
    2017-01-18
  • 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' complaint investigation has confirmed that the 'low calibrator deviation' calibration parameter may fall below the acceptable range causing an invalid calibration status which prevents customers from generating results for the bnp assay. when valid calibration and quality control (qc) are obtained patient results are valid and acceptable for reporting. when valid calibration is not achieved qc and patient testing cannot be performed.

Device

ADVIA CENTAUR CP SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
  • Model / Serial
    Model Catalog: 02816634 (Lot serial: Ending in 191); Model Catalog: 02816138 (Lot serial: Ending in 191); Model Catalog: 02816634 (Lot serial: Ending in 189); Model Catalog: 02816138 (Lot serial: Ending in 189); Model Catalog: 02816634 (Lot serial: Ending in 188); Model Catalog: 02816634 (Lot serial: Ending in 186); Model Catalog: (Lot serial: Ending in 191); Model Catalog: (Lot serial: Ending in 189); Model Catalog: (Lot serial: Ending in 188); Model Catalog: (Lot serial: Ending in 186); Model Catalog: 02816138 (Lot serial: Ending in 186); Model Catalog: 02816138 (Lot serial: Ending in 188)
  • Product Description
    B-type Natriuretic Peptide (BNP) 100 test kit;B-type Natriuretic Peptide (BNP) 500 test kit
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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