CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD… recallZ-1345-2022 · Menarini Silicon Biosystems · initiated May 20, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Menarini Silicon Biosystems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
Menarini Silicon Biosystems issued notification telephone Urgent Medical Device Correction Notification CTC Kit Lot S108 to US on 5/20/22. Followed by e-mail direct to consignees for US sites - May 23, 2022 and Coordination with Asia Pacific region and the EU with Local QA and RA from the regions. Letter states reason for recall, health risk and action to take: Discontinue usage of Lot S108 and quarantine the lot in your inventory for disposal. Review patient samples run with Kit Lot S108 which had results that were above the cut-off. If you observe any images with the staining pattern of the false positive images shown below or there is any uncertainty regarding these images impacting the patient's outcome from below the cutoff to above the cut-off, the patient sample should be repeated. Report any previous occurrence of unusually high number of total images/ unassigned events or potential false positive events that have not already been reported to the Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than May 31, 2022. If you have additional questions about this issue, contact Customer Technical Support at +1-877-837-4339 option 2
Recall details
- Recall number
- Z-1345-2022
- Status
- Open, Classified
- Initiated by the company
- May 20, 2022
- Recalling firm
- Menarini Silicon Biosystems
- Quantity
- 484 units
- Product code
- NQI
- FDA submissions
- K103502
- Distribution
- CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CellSearch 7900001Menarini Silicon Biosystems, Inc. · SYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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