Events

Recall of Device Recall Granada Biphasic Broth

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
    72760
  • Event Risk Class
    Class 2
  • Event Number
    Z-0556-2016
  • Event Initiated Date
    2015-11-23
  • Event Date Posted
    2015-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142164
  • 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
    selective medium for the screening and identification - Product Code NJR
  • Reason
    Fda has determined that the product requires 510(k) clearance to continue marketing/distribution in the united states.
  • Action
    The firm, Biomerieux, sent an "Urgent Product Removal Notice" dated November 23, 2015 to its consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to confirm that the letter has been distributed and reviewed by all appropriate personnel, discontinue and discard any remaining inventory, store letter with your bioMerieux documentation and complete the attached Acknowledgement Form via fax to: (919) 620-3306 attention of: bioMerieux NA ComOps QA/RA. If you have any questions or concerns, please contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.

Device

Device Recall Granada Biphasic Broth
  • Model / Serial
    REF 42722 - Lot Numbers 896, 897 & 899
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
  • Product Description
    Granada Biphasic Broth || The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Manufacturer Address
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA