Events

Recall of Device Recall Bac T/ALERT 3D 60

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    32377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0614-05
  • Event Initiated Date
    2005-05-27
  • Event Date Posted
    2005-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39928
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Blood Culturing - Product Code MDB
  • Reason
    A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
  • Action
    Consignees were notified by letter on May 27, 2005.

Device

Device Recall Bac T/ALERT 3D 60
  • Model / Serial
    All Models (Not available in the US)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, Turkey, UK
  • Product Description
    Bac T/ALERT¿ 3D 60
  • Manufacturer
    BIOMERIEUX, INC.

Manufacturer

BIOMERIEUX, INC.
  • Manufacturer Address
    BIOMERIEUX, INC., 100 Rodolphe St, Durham NC 27712-9402
  • Source
    USFDA