BEUDAMED
    FDA Recall Terminated

    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

    Recall: Z-0043-2012 · Initiated April 4, 2011

    Recall

    Recall Number
    Z-0043-2012
    Event Number
    58746
    Firm
    EMD Chemicals Inc.
    FEI Number
    2244894
    Product Code
    KQC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 4, 2011
    Posted
    October 12, 2011
    Terminated
    October 13, 2011
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239

    Description

    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

    Reason

    Stains may yield lower then expected absorbance levels resulting in under stained hematology specimens.

    Action

    EMD Chemicals Inc. sent an "IMPORTANT PRODUCT RECALL" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. An attached response form is included for customers to complete and return via fax to EMD Chemicals at 856-423-6314. Any questions concerning this recall notice should be directed to EMD Chemicals Technical Service Department at 1-800-222-0342.

    Distribution

    USA Distribution in the states of PA and NY.

    Quantity

    36 units