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.
FDA Recall Z-0976-2010 · Posted 2010-03-04
Recalling FirmSigma-Aldrich Mfg LLC
Recall StatusTerminated
Product CodeJCF
Date Initiated2009-12-08
Date Terminated2012-04-10
Product Quantity11,015/100-ml. btls; 5,745/6/100-ml btl packages; and 14,872/500-ml. btls.
Reason for Recall
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.