Events

Recall of Device Recall BacT/ALERT Classic (Only) with BacT/VIEW Software

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
    37136
  • Event Risk Class
    Class 2
  • Event Number
    Z-0814-2007
  • Event Initiated Date
    2006-12-19
  • Event Date Posted
    2007-05-18
  • 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=49959
  • 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
    in vitro diagnostic database software. - Product Code MDB
  • Reason
    Bact/view will be unable to run scheduled macro applications unless the user touches the bact/view touch screen or clicks a function after resynchronizing the clocks.
  • Action
    A customer notification was sent on/about December 19, 2006. Customers will be sent a new BacT/VIEW software version C.30b QTR 1 2007.

Device

Device Recall BacT/ALERT Classic (Only) with BacT/VIEW Software
  • Model / Serial
    Product Numbers: Software Version C.30a -22105-68, Update Disk; 22105-69 Install Disk
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
  • Product Description
    BacT/VIEW¿ Software, all versions. in vitro diagnostic database software.
  • 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