Recall Z-1530-2018— Menarini Silicon Biosystems
Class II · Terminated
Class II FDA medical device recall by Menarini Silicon Biosystems, initiated 2018-04-04, terminated 2019-04-09. It names one FDA 510(k) clearance: K103502. Product: CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.. Reason: Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results..
- Recalling firm
- Menarini Silicon Biosystems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-04
- Terminated
- 2019-04-09
- 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 Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
Reason for recall
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.