Device 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
Z-1345-2022
Product summary
- Event
- Event 90417
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 484 units
- Official record key
device-enforcement:Z-1345-2022
Official wording
Reason: 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
Code information: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
Distribution pattern: CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Derived failure modes
-
Unknown
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