2 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
FDA Recall
Terminated
·Menarini Silicon Biosystems·Product code NQI·April 4, 2018
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
FDA Enforcement
Class II
·Terminated·Menarini Silicon Biosystems·May 2, 2018