ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configu...
FDA Recall #Z-0987-2015 — Class II — December 16, 2014
Product Description
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 consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Reason for Recall
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Newark, DE
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7
Distribution
Distributed in the state of WA.
Code Information
CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated