Recall Z-1345-2022— Menarini Silicon Biosystems
Class II · Ongoing
Class II FDA medical device recall by Menarini Silicon Biosystems, initiated 2022-05-20. It names one FDA 510(k) clearance: K103502. 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. 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.
- Recalling firm
- Menarini Silicon Biosystems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-20
- Firm location
- Huntingdon Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.