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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 May 19, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on April 27, 2018
Recall Number Z-1957-2015
Recall Event ID 71362
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product CentraLink" Data Management 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 Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881,   Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181
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		 Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens sent an Urgent Medical Device Correction letter dated May 19, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer When using any of the CentraLink sample queries, do not select Instrument or Instrument Group criteria for Dimension Vista 500 or Dimension Vista 1500. This would also include any preconfigured queries, commands or tool bar buttons that may use these criteria. Your local Siemens service provider will be contacting you to verify and/or update the configuration of your CentraLink system. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (800) 441-9250.
Quantity in Commerce 1941
Distribution Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.
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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