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

Recall Z-0987-2015 — ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolida

U.S. FDA — Device Enforcement · United States · 2014-12-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0987-2015
Date of alert
2014-12-16
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)
10817209
Reported risk: Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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