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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.

FDA Recall Z-0974-2010 · Posted 2010-03-04

Recalling FirmSigma-Aldrich Mfg LLC
Recall StatusTerminated
Product CodeJCF
Date Initiated2009-09-04
Date Terminated2012-04-10
Product Quantity6,808/500-ml. bottles

Reason for Recall

Some of the product was contaminated with Pseudomonas mendocina

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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