Events

Recall of BacT/ALERT

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
    36826
  • Event Risk Class
    Class 2
  • Event Number
    Z-0774-2007
  • Event Initiated Date
    2006-08-14
  • Event Date Posted
    2007-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49411
  • 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
    Blood Culturing System - Product Code MDB
  • Reason
    Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on bact/alert microbial detection systems.
  • Action
    Consignees were notified via A Field Corrective Action Notification on/about 10/18/2006. A second notification was sent on October 31, 2006.

Device

BacT/ALERT
  • Model / Serial
    All Models
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dutch Antilles, Egypt, Ecuador, Estonia, Faeroe Islands, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Korea, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania , Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Product Description
    BacT/ALERT 3D 60 Systems Software, Blood Culturing System
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA