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.
What this means for you
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
- Hazard
- false-positive-results
- image-processing-error
Distribution
Distributed in 12 states:
- CA
- FL
- IL
- IN
- MA
- MI
- NC
- NM
- NY
- OH
- PA
- TX
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