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
Check against the official notice below — it lists the full affected range.
Menarini Silicon Biosystems is recalling the CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD, a medical device used to count circulating tumor cells in patient samples. The recall affects 484 units with lot number S108 and an expiration date of October 4, 2022, distributed across multiple U.S. states and internationally. The device has a defect that may produce an unusually high number of images containing unassigned events, including dual positives, which could result in false positive results appearing in the image gallery for some patient samples.
This defect could potentially affect the accuracy of test results, leading clinicians to misinterpret patient data. The source document does not specify what consumers or patients should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore, Quantity: 484 units Lot/code info: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.