CELLSEARCH Circulating Tumor Cell Kit Recalled for False Positive Risk
Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a diagnostic device with the potential for false positive results, which could affect clinical decision-making. However, no illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
The CELLSEARCH Circulating Tumor Cell Kit (Epithelial) is an in-vitro diagnostic device used to count circulating tumor cells in blood samples. This recall affects 484 units (Lot S108, expiration October 4, 2022) distributed across multiple U.S. states and international locations.
The manufacturer, Menarini Silicon Biosystems, is recalling the product due to a high number of unassigned images and events in the system, including dual positives. These events have the potential to generate false positive results that may be placed into the device's image gallery for some patient samples.
No illnesses or injuries have been reported. Healthcare facilities currently using this device should consult the FDA and manufacturer for instructions regarding existing test results and inventory management.
The recalled product
- Product
- 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
- Manufacturer
- Menarini Silicon Biosystems
- Affected units
- 484
Distribution
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