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U.S. Department of Health and Human Services

Class 2 Device Recall CentraLink Data Management System

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  Class 2 Device Recall CentraLink Data Management System see related information
Date Initiated by Firm December 16, 2014
Date Posted January 15, 2015
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-0987-2015
Recall Event ID 70078
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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.
Code Information CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by firm
Action A Siemens service provider visited each site to verify and/or update customer configuration on the ADVIA Chemistry XPT and CentraLink Systems to ensure proper reporting of results. An Urgent Medical Device Correction letter was issued on December 16, 2014 to all affected customers. Customers were also provided a Customer Bulletin providing instructions on how configuration setting should remain.
Quantity in Commerce 7
Distribution Distributed in the state of WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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