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

Recall Z-1500-2016 — ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories

U.S. FDA — Device Enforcement · United States · 2016-03-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1500-2016
Date of alert
2016-03-10
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)
11170842
Reported risk: Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively. The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. As defined in t
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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