Events

Recall of SYSMEX BLOOD COAGULATION ANALYZER CA-540

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
    18726
  • Event Risk Class
    II
  • Event Initiated Date
    2005-07-22
  • 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
    Manufacturer has found an issue when using the akima method of calculating the standard curve. a change to the standard curve method for this assay is needed.

Device

SYSMEX BLOOD COAGULATION ANALYZER CA-540
  • Model / Serial
    Model Catalog: B4260-540 (Lot serial: A2858); Model Catalog: B4260-540 (Lot serial: A3616); Model Catalog: B4260-540 (Lot serial: A2337); Model Catalog: B4260-540 (Lot serial: A3927); Model Catalog: B4260-540 (Lot serial: A3783); Model Catalog: B4260-540 (Lot serial: A3667); Model Catalog: B4260-540 (Lot serial: A3476); Model Catalog: B4260-540 (Lot serial: A1457); Model Catalog: B4260-540 (Lot serial: A3772); Model Catalog: B4260-540 (Lot serial: A3662); Model Catalog: B4260-540 (Lot serial: A3448); Model Catalog: B4260-540 (Lot serial: A3318); Model Catalog: B4260-540 (Lot serial: A3311); Model Catalog: B4260-540 (Lot serial: A2951); Model Catalog: B4260-540 (Lot serial: A3296); Model Catalog: B4260-540 (Lot serial: A3405); Model Catalog: B4260-540 (Lot serial: A2955); Model Catalog: B4260-540 (Lot serial: A2840); Model Catalog: B4260-540 (Lot serial: A2395); Model Catalog: B4260-540 (Lot serial: A1450); Model Catalog: B4260-540 (Lot serial: A2490); Model Catalog: B4260-540 (Lot serial: A3475); Model Catal
  • Product Description
    CA540 INSTRUMENT
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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