BEUDAMED
    FDA Recall Terminated

    Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. 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-0976-2010 · Initiated December 8, 2009

    Recall

    Recall Number
    Z-0976-2010
    Event Number
    53956
    Firm
    Sigma-Aldrich Mfg LLC
    FEI Number
    1938173
    Product Code
    JCF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 8, 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 100- and 500-ml. btls. and a 6x100-ml. bottle package. 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

    Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.

    Action

    The recalling firm issued an "Urgent Field Correction" notice dated December 7, 2009 via regular mail on December 8, 2009 which explains the reason for the field correction and instructs the user to review the enclosed, revised Instructions for Use (IFU) prior to further use of the product. The customer is requested to complete the acknowledgement information and return it to the recalling firm via FAX or e-mail. Direct questions to Sigma-Aldrich by calling 1-800-505-6275, extension 1232.

    Distribution

    Worldwide Distribution -- United States, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa.

    Quantity

    11,015/100-ml. btls; 5,745/6/100-ml btl packages; and 14,872/500-ml. btls.