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
    26788
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-08
  • 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
    There may be an incorrect side label on a small percentage of the advia centaur systems bnp readypacks from reagent lot 038174. incorrectly labeled readypacks are included within kit lots 43305174 43278174 43306174 and 43279174. the human-readable side label may incorrectly identify the readypack as advia centaur systems ft4 readypack. the readypack end label and the barcode end label correctly identify the readypack as the advia centaur systems bnp readypack and the readypack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labeled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted.

Device

ADVIA CENTAUR CP SYSTEM - B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
  • Model / Serial
    Model Catalog: 02816634 (Lot serial: 43278174); Model Catalog: 02816138 (Lot serial: 43305174); Model Catalog: 02816634 (Lot serial: 43305174); Model Catalog: 02816634 (Lot serial: 43279174); Model Catalog: 02816138 (Lot serial: 43279174); Model Catalog: 02816634 (Lot serial: 43306174); Model Catalog: 02816138 (Lot serial: 43306174); Model Catalog: 02816138 (Lot serial: 43278174)
  • 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