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

Recall Z-0597-2025 — Atellica CI Analyzer. Catalog Numbers: 10947347.

U.S. FDA — Device Enforcement · United States · 2024-11-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0597-2025
Date of alert
2024-11-04
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)
630414229560
Reported risk: Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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