BEUDAMED
    FDA Recall Terminated

    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.

    Recall: Z-0974-2010 · Initiated September 4, 2009

    Recall

    Recall Number
    Z-0974-2010
    Event Number
    53560
    Firm
    Sigma-Aldrich Mfg LLC
    FEI Number
    1938173
    Product Code
    JCF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 4, 2009
    Posted
    March 4, 2010
    Terminated
    April 10, 2012
    Address
    545 S Ewing Ave, Saint Louis, MO, 63103-2932

    Description

    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes.

    Reason

    Some of the product was contaminated with Pseudomonas mendocina

    Action

    An "IMPORTANT PRODUCT NOTIFICATION" dated September 4, 2009 was sent to customers via regular mail. The notification letter described product, problem and action to be taken. The customers were requested to immediately discontinue use of the product and discard all remaining material. Subrecall was requested if the product was further distributed. The customer is to complete and fax the notification form to (314) 286-7829 to assure proper replacement for material they have not used and which is to be discarded. Should you have any questions, please contact Signma-Aldrich Technical Service at (800) 325-5832.

    Distribution

    Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.

    Quantity

    6,808/500-ml. bottles