Events

Recall of BFA/BCT DISPO-SYSTEM CUVETTES

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
    49713
  • Event Risk Class
    II
  • Event Initiated Date
    2004-10-14
  • 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 determined a potential for incorrectly shortened coagulation times.

Device

BFA/BCT DISPO-SYSTEM CUVETTES
  • Model / Serial
    Model Catalog: OVFR032 (Lot serial: G42976-F3218.); Model Catalog: OVFR032 (Lot serial: G42374-C3098 G42374-D3068); Model Catalog: OVFR032 (Lot serial: G41682-F3178 G41682-K3038); Model Catalog: OVFR032 (Lot serial: G41682-C3128 G41682-K3038); Model Catalog: OVFR032 (Lot serial: G41506-C3048 G41506-C3138); Model Catalog: OVFR032 (Lot serial: G41250-C3058 G41250-D3028); Model Catalog: OVFR032 (Lot serial: G41034-C3058 G41034-D3098); Model Catalog: OVFR032 (Lot serial: G40990-D3098 G40990-D3118); Model Catalog: OVFR032 (Lot serial: G36409-C3018 G40472-D3119); Model Catalog: OVFR032 (Lot serial: G36098-B3028 G36409-B3038); Model Catalog: OVFR032 (Lot serial: G36098-A3138 G36098-A3188); Model Catalog: OVFR032 (Lot serial: G36272-A3188 G36272-B3038); Model Catalog: OVFR032 (Lot serial: G42570-D3138 G41974-C3208); Model Catalog: OVFR032 (Lot serial: G41974-D3048 G42976-F3138); Model Catalog: OVFR032 (Lot serial: G42570-C3098 G42570-C3148); Model Catalog: OVFR032 (Lot serial: G42209-D3048 G42209-D3068)
  • Product Description
    BFA/BCT DISPO-SYSTEM CUVETTES 6BAGS/PK
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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