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Terminated

Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO. The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077.

FDA Recall Z-0977-2010 · Posted 2010-03-04

Recalling FirmSigma-Aldrich Mfg LLC
Recall StatusTerminated
Product CodeJCF
Date Initiated2009-12-08
Date Terminated2012-04-10
Product Quantity8,640/100-ml. btls and 3,138/6/100-ml. btl packages

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.

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