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
    67371
  • Event Risk Class
    III
  • Event Initiated Date
    2012-07-09
  • 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
    Sysmex has identified a software bug with cs-2000i and cs-2100i software version 60 (v00-60) and all previous software versions. in the software certain error flags highlighted for review are automatically validated and sent to the host computer. these error flags are not being held back for manual review as expected.

Device

SYSMEX BLOOD COAGULATION ANALYZER CS-2000I
  • Model / Serial
    Model Catalog: 06317410 (Lot serial: 11358); Model Catalog: 06372511 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    SYSMEX CS-2000I SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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