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
    36239
  • Event Risk Class
    Class 2
  • Event Number
    Z-0243-2007
  • Event Initiated Date
    2006-08-17
  • Event Date Posted
    2006-12-05
  • 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=48238
  • 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
    Culture bottle (anaerobic) - Product Code MDB
  • Reason
    Recovery compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times.
  • Action
    Affected Customers were notified of this recall on August 18, 2006 and August 21, 2006 via phone and instructed to destroy product remaining in stock.

Device

BacT/ALERT
  • Model / Serial
    Lot number 1013177 (Product No. 259790)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution ---- including states of AL, CA, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, MT, NC, NE, NJ, NY, OH, PA, RI, TX, VA, WA, WI, and WV.
  • Product Description
    bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
  • 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