Events

Recall of N/T RHEUMATOLOGY CONTROL SL

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
    100723
  • Event Risk Class
    III
  • Event Initiated Date
    2006-06-22
  • 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
    A discrepancy between rf values when compared to who 64/002 an overestimation of rf vales by approximately 50% may be observed when used to calibrate n latex rf assays.

Device

N/T RHEUMATOLOGY CONTROL SL
  • Model / Serial
    Model Catalog: OQDC13 (Lot serial: 183834 TO 18836A); Model Catalog: OQKZ13 (Lot serial: 199551 TO 199553B); Model Catalog: OQDB13 (Lot serial: 183834 TO 18836A); Model Catalog: OQKZ13 (Lot serial: 199451 TO 199453A)
  • Product Description
    N RHEUMATOLOGY STANDARD SL
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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