FDAFDA · Food and drugs·Recall number Z-1530-2018
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.
Published May 2, 2018 · Recall initiated: April 4, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Menarini Silicon Biosystems
- Distributor
- Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
- Lot
- UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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