Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CA-1500

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
    28908
  • Event Risk Class
    II
  • Event Initiated Date
    2002-08-27
  • 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
    Certain lis units may intermittently not respond within the specified time frame as a result incorrect patient order information could be returned and assigned to the wrong tube by the host computer.

Device

SYSMEX BLOOD COAGULATION ANALYZER CA-1500
  • Model / Serial
    Model Catalog: CA-1500CP (Lot serial: A2483.); Model Catalog: CA-1500WBCR (Lot serial: A2483.); Model Catalog: CA-1500CP (Lot serial: A1581 A2270 A1888 A2427); Model Catalog: CA-1500WBCR (Lot serial: A1581 A2270 A1888 A2427); Model Catalog: CA-1500CP (Lot serial: A1105 A2401 A2399 A2400); Model Catalog: CA-1500WBCR (Lot serial: A1105 A2401 A2399 A2400); Model Catalog: CA-1500CP (Lot serial: A2269 A2271 A2171 A1556); Model Catalog: CA-1500WBCR (Lot serial: A2269 A2271 A2171 A1556); Model Catalog: CA-1500CP (Lot serial: A2182 A2257 A2296 A2486); Model Catalog: CA-1500WBCR (Lot serial: A2182 A2257 A2296 A2486); Model Catalog: CA-1500CP (Lot serial: A1825 A1644 A1874 A1646); Model Catalog: CA-1500WBCR (Lot serial: A1825 A1644 A1874 A1646); Model Catalog: CA-1500CP (Lot serial: A1465 A2480 A2320 A1151); Model Catalog: CA-1500WBCR (Lot serial: A1465 A2480 A2320 A1151)
  • Product Description
    CA-1500 COAGULATION ANALYZER
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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