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Lympho-Kwik T Lymphocyte, 25 isolations
ONE LAMBDA, INC. · Model N/A · UDI-DI 00812117018799
JCF
Prescription
10
510(k) clearances
293
Adverse events
4
Recalls
13
Facilities
Description
Lympho-Kwik provides a simple procedure for the isolation of lymphocytes for use in the HLA typing assay.
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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Get your free API keyRead the docsData 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.