FDA-Device2022-07-13Class II
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
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
Sold states
CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Affected count
484 units
Manufactured in
3401 Masons Mill Rd Ste 100, N/A, Huntingdon Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1345-2022Don't want to check this manually?
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