Events

Recall of ADVIA 560 HEMATOLOGY ANALYZER

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
    53043
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-22
  • 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 is investigating an issue on the advia 560 hematology system which may cause an incorrect result to be reported. siemens has received two reports of multiple discordant records for the same sample id (sid) in the advia 560 hematology system database that occurred during the installation of the systems. the database should only contain one record of a sample id number for any given time and date. if there are multiple records for the same sample id it is possible that multiple results may be manually or automatically sent to the laboratory information system (lis) printed or displayed on the results report screen.

Device

ADVIA 560 HEMATOLOGY ANALYZER
  • Model / Serial
    Model Catalog: 11170842 (Lot serial: ALL)
  • Product Description
    ADVIA 560 HEMATOLOGY ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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