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Terminated

Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

FDA Recall Z-2406-2015 · Posted 2015-08-18

Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeNQI
Date Initiated2015-05-15
Date Terminated2016-03-30
Product Quantity1560 kits

Reason for Recall

Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

Firm Action

Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution.

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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