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Leucosep Tubes

Oxford Immunotec, Inc. · Model LTK.615 · UDI-DI 05051716000087

JCF

510(k) clearances

293

Adverse events

Recalls

Facilities

Description

Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.