Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CA-1000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE BEHRING CANADA INC..

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
    62031
  • Event Risk Class
    III
  • Event Initiated Date
    2000-09-07
  • 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
    Potential for the aptt analysis to detect an early reaction that may be integrated a short aptt clotting times by the analyzer especially with prolonged true aptt clotting times.

Device

SYSMEX BLOOD COAGULATION ANALYZER CA-1000
  • Model / Serial
    Model Catalog: B4260-5000 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B4260-1000 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    SYSMEX CA-1000 AUTOMATED COAGULATION AN
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

DADE BEHRING CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC