Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2406-2015 — Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

U.S. FDA — Device Enforcement · United States · 2015-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2406-2015
Date of alert
2015-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Veridex, LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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