Lymphocyte Separation Medium
FDA adverse event reports and recall history for lymphocyte separation medium (product code JCF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 289
- Deaths
- 0
- Injuries
- 2
- Malfunctions
- 286
Reports per year
Source: FDA adverse event reports by year received, 1994–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2014-08-22TerminatedUnder Investigation by firm
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
- 2010-03-04TerminatedOther
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.
Some of the product was contaminated with Pseudomonas mendocina
- 2010-03-04TerminatedOther
Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. btls. and a 6x100-ml. bottle package. 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.
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
- 2010-03-04TerminatedOther
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.
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
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