Events

Recall of SYVA RAPIDTEST TCA

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
    16086
  • Event Risk Class
    III
  • Event Initiated Date
    2001-03-13
  • 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
    The amount of nortripyline required to produce positive tca results is lower than the 1000 ng/ml cutoff listed in the product labeling.

Device

SYVA RAPIDTEST TCA
  • Model / Serial
    Model Catalog: 6A119UL (Lot serial: AYOJ25); Model Catalog: 6A269UL (Lot serial: CDOJ25)
  • Product Description
    RAPID TEST TRICYCLIC ANTIDEP 25 TESTS
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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