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

Recall Z-0723-2017 — ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

U.S. FDA — Device Enforcement · United States · 2016-10-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0723-2017
Date of alert
2016-10-21
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: Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
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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