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Menarini Silicon Biosystems recalls CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intend
Recalled May 2, 2018 · FDA recall Z-1530-2018 · Menarini Silicon Biosystems
Hazard
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results. · FDA Class II
Units
N/A
Sold at
Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Description
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
Product
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.
Manufacturer(s)
Menarini Silicon Biosystems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →