BEUDAMED
    FDA Recall Terminated

    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

    Recall: Z-0556-2016 · Initiated November 23, 2015

    Recall

    Recall Number
    Z-0556-2016
    Event Number
    72760
    Firm
    Biomerieux Inc
    FEI Number
    1950204
    Product Code
    NJR
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 23, 2015
    Posted
    December 29, 2015
    Terminated
    February 24, 2016
    Address
    595 Anglum Rd, Hazelwood, MO, 63042-2320

    Description

    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

    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 bioMrieux Clinical Customer Service organization at (800) 682-2666.

    Distribution

    US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.

    Quantity

    24 cartons