Z-1345-2022Class II

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor...

Name: Z-1345-2022 CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor...
Creator: Menarini Silicon Biosystems
Published: 2022-05-20
License: https://open.fda.gov/license/

Menarini Silicon Biosystems Inc. / initiated 2022-05-20 / Open, Classified / root cause: manufacturing process

FDA source

Menarini Silicon Biosystems began a recall of CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and... on 2022-05-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1345-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-07
Recalling firm: Menarini Silicon Biosystems Inc.
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
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
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
Root cause tag: manufacturing process
FDA 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 in commerce: 484 units
Distribution: CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,
Product codes and lots: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1345-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1345-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07

Product code NQI

K103502Class IICellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC / cleared 2010-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)