Events

Recall of BEHRING COAGULATION SYSTEM (BCS) - INSTRUMENT

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
    86060
  • Event Risk Class
    II
  • Event Initiated Date
    2010-11-05
  • 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
    This recall affects customers using the behring coagulation system (bcs). siemens has confirmed that if the cleaner scs vial becomes empty after processing a test for antithrombin assay using the innovance antithrombin kit and the test immediately following is an aptt based clotting assay several results might be falsely shortened. this is a very rare occurrence. customers who are not using innovance antithrombin on the bcs or bcs xp customers are not affected.

Device

BEHRING COAGULATION SYSTEM (BCS) - INSTRUMENT
  • Model / Serial
    10 numbers contact mfg")" v-b-tooltip> Model Catalog: OVIO03 (Lot serial: ">10 numbers contact mfg")
  • Product Description
    BEHRING COAGULATION SYSTEM (BCS)
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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