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U.S. Department of Health and Human Services

Class 2 Device Recall SigmaAldrich Histopaque1077

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  Class 2 Device Recall SigmaAldrich Histopaque1077 see related information
Date Initiated by Firm September 04, 2009
Date Posted March 04, 2010
Recall Status1 Terminated 3 on April 10, 2012
Recall Number Z-0974-2010
Recall Event ID 53560
Product Classification Lymphocyte separation medium - Product Code JCF
Product 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.
Code Information Lot #038K6170, Exp. 2011-04
Recalling Firm/
Sigma-Aldrich Mfg LLC
545 S Ewing Ave
Saint Louis MO 63103-2932
For Additional Information Contact Marilyn L. Baltz, Ph. D.
Manufacturer Reason
for Recall
Some of the product was contaminated with Pseudomonas mendocina
FDA Determined
Cause 2
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.
Quantity in Commerce 6,808/500-ml. bottles
Distribution Worldwide distribution: USA and Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.