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

Recall Z-1345-2022 — CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

U.S. FDA — Device Enforcement · United States · 2022-05-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1345-2022
Date of alert
2022-05-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Menarini Silicon Biosystems
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888385000016
Reported risk: High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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