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Terminated

Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003

FDA Recall Z-1472-2011 · Posted 2011-03-01

Recalling FirmVeridex, LLC
Recall StatusTerminated
Product CodeNRS
Date Initiated2010-11-09
Date Terminated2014-03-28
Product Quantity122 US, 28 International

Reason for Recall

There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.

Firm Action

Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.

Root Cause

Process control

Distribution Pattern

Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040898CELLSEARCH EPITHELIAL CELL CONTROL KITVeridex, LLC · 2004-06-28

Official Source

View FDA Recall →

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

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