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Veridex, LLC recalls Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in
Recalled August 26, 2015 · FDA recall Z-2406-2015 · Veridex
Hazard
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells. · FDA Class II
Units
1560 kits
Sold at
Nationwide Distribution.
Description
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
Product
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Manufacturer(s)
Veridex, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →