Lymphocyte Separation Medium
Hematology · 21 CFR 864.8500
Recent MDR events
293 adverse event reports on file
- BD Vacutainer® CPT¿ Cell Preparation Tube with Sodium CitrateJul 29, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00671
- BD Vacutainer® CPT¿ Cell Preparation Tube with Sodium CitrateJul 27, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00642
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJul 13, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00609
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJul 7, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00595
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJun 22, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00557
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJun 19, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00554
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJun 18, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00548
- BD VACUTAINER® CPT NH: 130 IU FICOLL 2.0MLJun 17, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00544
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJun 10, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00526
- BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATEJun 4, 2026MalfunctionBecton Dickinson & Co (franklin Lakes)1917413-2026-00495
Event type breakdown
Recalls
4 recall events for this product code
- Becton Dickinson & CompanyTerminatedAug 22, 2014
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 collecti
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.
Z-2542-2014 · View FDA record ↗ - Sigma-Aldrich Mfg LLCTerminatedMar 4, 2010
Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. btls. The firm name on the label is Sigma-Aldrich, Inc., St. Louis, MO.
Some of the product was contaminated with Pseudomonas mendocina
Z-0974-2010 · View FDA record ↗ - Sigma-Aldrich Mfg LLCTerminatedMar 4, 2010
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.
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
Z-0976-2010 · View FDA record ↗ - Sigma-Aldrich Mfg LLCTerminatedMar 4, 2010
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,
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
Z-0977-2010 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Stemcell Technologies
Vancouver British Columbia, CA
Cedarlane Corporation
BURLINGTON Ontario, CA
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Thermo Fisher Scientific Baltics Uab
Vilnius Vilniaus Miestas, LT
One Lambda, Inc.
West Hills, CA, US
Cytetech Limited
Burgess Hill West Sussex, GB
Lonza Walkersville, Inc.
WALKERSVILLE, MD, US
Columbia Plastics Ltd.
Surrey British Columbia, CA
Becton Dickinson
FRANKLIN LAKES, NJ, US
Lonza Verviers Srl.
Verviers Liege, BE
One Lambda, Inc
Hennigsdorf Brandenburg, DE
Becton, Dickinson & Co.
BROKEN BOW, NE, US
Aivita Biomedical, Inc.
Irvine, CA, US
510(k) clearances
12 clearances for this product code
- Bd Becton Dickinson Vacutainer Systems PreanalyticDec 15, 1992
K911731 · LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR
- Icn Biomedicals, Inc.Aug 22, 1990
K902445 · LYMPHO SEP(TM)
- Bd Becton Dickinson Vacutainer Systems PreanalyticMay 26, 1989
K891407 · LEUCOPREP CELL SEPARATION TUBE
- E.I. Dupont DE Nemours & Co., Inc.Feb 16, 1988
K874328 · L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA
- Dynal Biotech, Inc.Nov 4, 1987
K873185 · DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
- Bd Becton Dickinson Vacutainer Systems PreanalyticOct 2, 1987
K872775 · LEUCOPREP BRAND TUBE
- Sepratech Corporation C/O Keller and HeckmanApr 18, 1986
K860354 · SEPRACELL LYMPHOCYTE SEPARATION MEDIUM
- Bd Becton Dickinson Vacutainer Systems PreanalyticNov 12, 1985
K854093 · LEUCO PREP