Events

Recall of ADVIA CENTAUR SYSTEM - CREATINE KINASE-MB (CKMB) 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
    26725
  • Event Risk Class
    III
  • Event Initiated Date
    2018-02-28
  • 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 calibration flag "invalid exceeded defined ranges" may be triggered due to the slope value exceeding the acceptable range. the resulting invalid calibration prevents customers from generating ckmb results. when valid calibrations and in range quality control (qc) results are obtained patient results are valid and acceptable for reporting. when an invalid calibration is received qc and patient testing cannot be performed.

Device

ADVIA CENTAUR SYSTEM - CREATINE KINASE-MB (CKMB) ASSAY
  • Model / Serial
    Model Catalog: 00481201 (Lot serial: 62277209); Model Catalog: 07516647 (Lot serial: 51807209); Model Catalog: 07516647 (Lot serial: 62277209); Model Catalog: 00481201 (Lot serial: 51806209); Model Catalog: 07516647 (Lot serial: 61702209); Model Catalog: 00481201 (Lot serial: 61702209); Model Catalog: 07516647 (Lot serial: 51806209); Model Catalog: 00481201 (Lot serial: 51807209)
  • Product Description
    ADVIA CENTAUR SYSTEM-CREATINE KINASE-MB (CKMB) ASSAY;ADVIA CENTAUR CP SYSTEM-CREATINE KINASE-MB (CKMB) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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