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 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
    70428
  • Event Risk Class
    III
  • Event Initiated Date
    2007-08-14
  • 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
    When the observa system is interfaced to a laboratory information management system (lis) some error conditions may cause a delay in reporting positive cultures to the lis.

Device

OBSERVA R02 BACT/ALERT 3D
  • Model / Serial
    Model Catalog: R02.00.17 (Lot serial: VERSION R01.0016); Model Catalog: R01.00.16 (Lot serial: VERSION R01.0016); Model Catalog: R02.01.05 (Lot serial: VERSION R02.01.05); Model Catalog: R02.00.17 (Lot serial: VERSION R02.01.05); Model Catalog: R02.01.05 (Lot serial: VERSION R01.0016); Model Catalog: R02.01.05 (Lot serial: VERSION R02.00.17); Model Catalog: R02.00.17 (Lot serial: VERSION R02.00.17); Model Catalog: R01.00.16 (Lot serial: VERSION R02.00.17); Model Catalog: R01.00.16 (Lot serial: VERSION R02.01.05)
  • Product Description
    OBSERVA software
  • Manufacturer
    BIOMERIEUX INC.

Manufacturer

BIOMERIEUX INC.