FDA Medical Device Recalls (openFDA)
Menarini Silicon Biosystems: 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
- Recall number
- Z-1345-2022
- Recalling firm
- Menarini Silicon Biosystems
- 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
- Status
- Open, Classified
- Initiated
- 2022-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Root cause
- Process control
- Action
- 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
- Quantity
- 484 units
- Distribution
- CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
- Lot, serial or model codes
- UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
- 510(k) numbers
- ["K103502"]
- PMA numbers
- not on file
- Product code
- NQI
- Firm FEI
- 3004153557
- Firm city
- Huntingdon Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28