Events

Recall of SYVA RAPID TEST DAU-4

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
    26618
  • Event Risk Class
    III
  • Event Initiated Date
    1999-03-15
  • 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 read time window as stated in the package insert (3 to 10 minutes) is incorrect. reading the cassette earlier than 5 minutes may result in non optional colour and a false interpretation.

Device

SYVA RAPID TEST DAU-4
  • Model / Serial
    Model Catalog: CAT # 6A199UL 6A219UL (Lot serial: ALL)
  • Product Description
    SYVA RAPID TEST DAU-4
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

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