Sigma-Aldrich Mfg LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sigma-Aldrich Mfg LLC
Lot Codes / Batch Numbers
Lots 038K6030, 126K6002, and 079K6047.
Products Sold
Lots 038K6030, 126K6002, and 079K6047.
Sigma-Aldrich Mfg LLC is recalling Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. btls and 6x100-ml. btl packages. Th due to Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026