Events

Recall of STACLOT LA 20 IVD REAGENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STAGO CANADA LTD./STAGO CANADA LTEE.

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
    135267
  • Event Risk Class
    II
  • Event Initiated Date
    2010-02-04
  • 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
    Internal investigations have determined that certain lots of the roduct were marketed in canada utilizing the incorrect reference number and consequently without proper registration with health canada (unlicenced device). however there is an equivalent product utilizing a different reference that is properly registered with health canada. there is no functional difference between the two product reference numbers with the exception of the number of tests that can be conducted.

Device

STACLOT LA 20 IVD REAGENT
  • Model / Serial
    Model Catalog: 0594 (Lot serial: 104679); Model Catalog: 0594 (Lot serial: 104449); Model Catalog: 0594 (Lot serial: 102788); Model Catalog: 58230 (Lot serial: 8047402); Model Catalog: 58230 (Lot serial: 7086966); Model Catalog: 58230 (Lot serial: 7117121); Model Catalog: 58230 (Lot serial: 8047411); Model Catalog: 58230 (Lot serial: 8027323); Model Catalog: 58230 (Lot serial: 8027328); Model Catalog: 58230 (Lot serial: 8047404); Model Catalog: 58230 (Lot serial: 8027325); Model Catalog: 58230 (Lot serial: 8047409); Model Catalog: 58230 (Lot serial: 8047401); Model Catalog: 58230 (Lot serial: 8017261); Model Catalog: 58230 (Lot serial: 8027317); Model Catalog: 58230 (Lot serial: 7086963)
  • Product Description
    STACLOT LA 20
  • Manufacturer
    STAGO CANADA LTD./STAGO CANADA LTEE

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE