Z-1530-2018 Class II Terminated
FDA device recall Z-1530-2018 was initiated by Menarini Silicon Biosystems on April 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated April 9, 2019). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- April 4, 2018
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Code Information
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)