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Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of
Recalled July 13, 2022 · FDA recall Z-1345-2022 · Menarini Silicon Biosystems
Hazard
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples · FDA Class II
Units
484 units
Sold at
CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Description
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
Product
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001
Manufacturer(s)
Menarini Silicon Biosystems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →