Z-0977-2010

Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm...

Name: Z-0977-2010 Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. The firm...
Creator: Sigma-Aldrich Mfg LLC
Published: 2009-12-08
License: https://open.fda.gov/license/

Sigma-Aldrich Manufacturing, LLC / initiated 2009-12-08 / Terminated / root cause: labeling and UDI

FDA source

Sigma-Aldrich Mfg LLC began a recall of 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... on 2009-12-08. The reason FDA records is "Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0977-2010
Status: Terminated
Initiated: 2009-12-08
Posted: 2010-03-04
Terminated: 2012-04-10
Recalling firm: Sigma-Aldrich Manufacturing, LLC
Product: 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.
Product code: JCF Lymphocyte Separation Medium
Reason for recall: Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 8,640/100-ml. btls and 3,138/6/100-ml. btl packages
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.
Product codes and lots: Lots 038K6030, 126K6002, and 079K6047.

Product code JCF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)