Home › Device types › JCF
Lymphocyte Separation Medium
FDA product code JCF · Class 1 · Hematology
53
Registered devices
295
Adverse events
4
Recalls
12
510(k) clearances
Devices with this code
BD Vacutainer® CPT™ Cell Preparation Tube with Sodium Heparin — BECTON, DICKINSON AND COMPANYX-Vivo10 w/o Gent, PR w/ Rec Transf, 10L — Lonza VerviersLympho-Kwik T/B Lymphocyte, 50 isolations — ONE LAMBDA, INC.STD X-Vivo 15 w/o gentamicin and pr, 5L — Lonza VerviersLympho-Kwik T Lymphocyte, 50 isolations — ONE LAMBDA, INC.Dynabeads™ HLA Cell Prep™ II — THERMO FISHER SCIENTIFIC BALTICS UABDynabeads™ HLA Cell Prep™ II — THERMO FISHER SCIENTIFIC BALTICS UABLympholyte-H — Cedarlane CorporationFluoroBeads™ T Developer (10X) — ONE LAMBDA, INC.Lympholyte-H — Cedarlane CorporationX-Vivo10 w/o Gent, PR w/ Rec Transf, 1L — Lonza VerviersLympho-Kwik T Lymphocyte, 25 isolations — ONE LAMBDA, INC.TheraPEAK® T-VIVO® MEDIUM 5L BAG — Lonza VerviersLympholyte-H — Cedarlane CorporationBD Vacutainer® CPT™ Cell Preparation Tube with Sodium Citrate — BECTON, DICKINSON AND COMPANYSepMate-50 — Stemcell Technologies Canada IncX-VIVO 15 w/o PR and Gentamicine 1L bag sample — Lonza VerviersFluorobeads™ T Lymphocyte – 100 Isolations — ONE LAMBDA, INC.TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1L — Lonza VerviersX-VIVO10(04-743) contains rec transf -1L — Lonza VerviersX-VIVO 15 w/o PR and Gentamicine 1L bag — Lonza VerviersX-Vivo15(04-744)contains rec tran 1L bag — Lonza VerviersLeucosep Tubes — Oxford Immunotec, Inc.TheraPEAK X-VIVO10(04-743) contains rec transf -1L — Lonza Verviers
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-07-03 | Becton Dickinson & Company | 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. |
| 2009-12-08 | Sigma-Aldrich Mfg LLC | Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances. |
| 2009-12-08 | Sigma-Aldrich Mfg LLC | Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances. |
| 2009-09-04 | Sigma-Aldrich Mfg LLC | Some of the product was contaminated with Pseudomonas mendocina |
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