BEUDAMED
    FDA Enforcement Class II Terminated

    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    Recall: Z-1314-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1314-2016
    Event ID
    73325
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Northeast Laboratory Services, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    December 21, 2015
    Classification Date
    April 1, 2016
    Termination Date
    April 7, 2016
    Address
    227 China Rd, N/A, Winslow, ME, 04901-0629, United States

    Description

    NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    Reason

    Product marketed without a 510 (k)

    Code Info

    Al lot codes

    Distribution

    Nationwide Distribution.

    Quantity

    11720