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SepMate-15
Stemcell Technologies Canada Inc · Model 85415 · UDI-DI 07540207854158
10
510(k) clearances
293
Adverse events
4
Recalls
13
Facilities
Description
SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone marrow by density centrifugation.
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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