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Terminated

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.

FDA Recall Z-1530-2018 · Posted None

Recalling FirmMenarini Silicon Biosystems
Recall StatusTerminated
Product CodeNQI
Date Initiated2018-04-04
Date Terminated2019-04-09

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.

Firm 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.

Root Cause

Process design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001Veridex, LLC · 2010-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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