Z-1530-2018Class II

CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is...

Name: Z-1530-2018 CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is...
Creator: Menarini Silicon Biosystems
Published: 2018-04-04
License: https://open.fda.gov/license/

Menarini Silicon Biosystems Inc. / initiated 2018-04-04 / Terminated / root cause: manufacturing process

FDA source

Menarini Silicon Biosystems began a recall of CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor... on 2018-04-04. FDA classified it as Class II and gives the reason as "Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1530-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-04
Posted: 2018-04-26
Terminated: 2019-04-09
Recalling firm: Menarini Silicon Biosystems Inc.
Product: CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
Product code: NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Reason for recall: Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Menarini silicon biosystems sent an Urgent Medical Device Correction Notification dated April 3, 2018. Required Actions. " Please dispose of any affected product in your current inventory . " Report any previous occurrence of unusually high number of total images I unassigned events in patient samples to Customer Technical Support. " Complete and return the enclosed Confirmation of Receipt form no later than April 20,2018. For further question, please call (215) 830-0777.
Distribution: Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Product codes and lots: UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1530-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1530-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

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)