BEUDAMED
    FDA Enforcement Class II Terminated

    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.

    Recall: Z-0470-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0470-2016
    Event ID
    72786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 30, 2015
    Initiation Date
    November 18, 2015
    Classification Date
    December 23, 2015
    Termination Date
    March 28, 2016
    Address
    1430 W McCoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    Description

    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.

    Reason

    The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.

    Code Info

    Cat. no. K31 Lot no.15231

    Distribution

    US. Distribution to the states of : CA, WI, MD and UT. .

    Quantity

    500 25pk/20)