BEUDAMED
    FDA Recall Terminated

    NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    Recall: Z-1313-2016 · Initiated December 21, 2015

    Recall

    Recall Number
    Z-1313-2016
    Event Number
    73325
    Firm
    Northeast Laboratory Services, Inc.
    FEI Number
    1210083
    Product Code
    JSI
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    December 21, 2015
    Posted
    April 1, 2016
    Terminated
    April 7, 2016
    Address
    227 China Rd, Winslow, ME, 04901-0629

    Description

    NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

    Reason

    Product marketed without a 510 (k)

    Action

    Northeast Laboratory services issued recall letter dated 2/29/16 and advised users to: Immediately examine your inventory for all lots of these products you may have in stock. Please destroy all remaining product in stock. Users requested to fill out the questionnaire immediately and return the questionnaire via email or Fax. Previously Northeast Laboratory Services notified users by letter dated 12/21/15 that the firm has discontinued the products effective January 2016. Alternative products were referenced in the letter for users to transition to replacement product.

    Distribution

    Nationwide Distribution.

    Quantity

    9300