Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CS-2000I

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
    76349
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-22
  • 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
    Under certain circumstances results could be assigned to a wrong sample. when the operator registers an order for micro mode and tries to modify the order by pushing the button in the order screen or the job list screen there is a risk of a mismatch between results and sample id numbers. the problem concerns qc as well as sample measurements which are measured in normal-mode. please note that this problem occurs even if no modification of the sample order has been done. pushing the button already triggers the error which is caused by a possible wrong feed forward of the sample rack.

Device

SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
  • Model / Serial
    Model Catalog: 10488584 (Lot serial: ALL); Model Catalog: CS-2100I (Lot serial: ALL); Model Catalog: 10488586 (Lot serial: ALL); Model Catalog: CS-2000I (Lot serial: ALL)
  • Product Description
    SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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