Events

Recall of OBSERVA R02 BACT/ALERT 3D

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX 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
    48233
  • Event Risk Class
    III
  • Event Initiated Date
    2011-10-19
  • 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
    An anomaly with all versions of observa has been identified that can cause positive and negative accessions to not be sent to the bottle lis. this anomaly can occur when results are received from the bact/alert 3d when observa is running a scheduled bottle lis link transmission and where the bottle lis connection has been configured to send new test results.

Device

OBSERVA R02 BACT/ALERT 3D
  • Model / Serial
    Model Catalog: 248035 (Lot serial: ); Model Catalog: 248027 (Lot serial: ); Model Catalog: 248029 (Lot serial: ); Model Catalog: 410462 (Lot serial: ); Model Catalog: 248036 (Lot serial: ); Model Catalog: 248056 (Lot serial: ); Model Catalog: 248055 (Lot serial: ); Model Catalog: 248043 (Lot serial: ); Model Catalog: 218039 (Lot serial: ); Model Catalog: 410461 (Lot serial: )
  • Product Description
    OBSERVA Database Management System
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.