Z-0974-2010

Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is...

Name: Z-0974-2010 Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is...
Creator: Sigma-Aldrich Mfg LLC
Published: 2009-09-04
License: https://open.fda.gov/license/

Sigma-Aldrich Manufacturing, LLC / initiated 2009-09-04 / Terminated

FDA source

Sigma-Aldrich Mfg LLC began a recall of 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... on 2009-09-04. The reason FDA records is "Some of the product was contaminated with Pseudomonas mendocina". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0974-2010
Status: Terminated
Initiated: 2009-09-04
Posted: 2010-03-04
Terminated: 2012-04-10
Recalling firm: Sigma-Aldrich Manufacturing, LLC
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.
Product code: JCF Lymphocyte Separation Medium
Reason for recall: Some of the product was contaminated with Pseudomonas mendocina
FDA root cause: Other
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.
Product codes and lots: Lot #038K6170, Exp. 2011-04

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)