Events

Recall of ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS

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
    136600
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-07
  • 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 has confirmed that the dbil_2 assigned calibrator values (acv) currently assigned to certain lots may cause on average a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. due to the proportional bias the differences become greater as the concentration of dbil_2 increases. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory quality control may not detect this issue.

Device

ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Model / Serial
    Model Catalog: 10312279 (Lot serial: 680726D); Model Catalog: 10312279 (Lot serial: 680726C); Model Catalog: 10312279 (Lot serial: 680726B); Model Catalog: 10312279 (Lot serial: 680726A); Model Catalog: 10312279 (Lot serial: 680726)
  • Product Description
    ADVIA CHEMISTRY SYSTEMS - CHEMISTRY CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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