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.
Check against the official notice below — it lists the full affected range.
The CELLSEARCH Circulating Tumor Cell Kit (Product Code 7900001), manufactured by Menarini Silicon Biosystems, has been recalled due to an unusually high number of total images and unassigned events that may require additional time and effort for operators to review. This issue may cause delays in reporting results. The affected kits were distributed worldwide, including throughout the USA, Canada, and Italy, and involve multiple lot numbers including S038, S038R, S038S, S038T, S038U, S038V, and S038W.
The source document does not specify a remedy or corrective action for consumers who have received affected kits.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy Quantity: N/A Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.