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

Recall Z-3063-2024 — Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

U.S. FDA — Device Enforcement · United States · 2024-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3063-2024
Date of alert
2024-07-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11097543
Reported risk: The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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