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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8

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  Class 2 Device Recall Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 see related information
Date Initiated by Firm October 30, 2013
Date Posted January 24, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-0823-2014
Recall Event ID 66694
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8

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 V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (Disabled Test in CentraLink System or Aptio System May Become Enabled in CentraLink System.)
FDA Determined
Cause 2
Software design
Action The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated October 23, 2013 to its customers. The firm also sent a follow-up letter dated October 30, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed Until a service visit is scheduled, do the following: Instruct the laboratory staff to recognize this sequence of events and Ensure that whenever the operator disables a method on an Aptio system or a CentraLinksystem and replenishes reagent for that method, the operator then confirms that the method remains disabled in the CentraLink system or disables it again. The operator must allow up to five minutes to verify that the test remains disabled. In addition, the customers were instructed tocomplete and return the FIELD CORRECTION EFFECTIVENESS CHECK response form via fax to Siemens Healthcare Diagnostics Customer Care Center at 800-441-9250, and to retain this letter with your laboratory records, and forward this letter to those who may have received this product. After a service visit is performed and an interim solution is implemented, the laboratory staff will be trained on this update to understand the minor but necessary changes in the workflow. If you have any questions, please contact your Siemens Customer Care Center at 800-441-9250 or your local Siemens representative.
Quantity in Commerce 40
Distribution US Distribution in the states of: MN, NJ, and NV.
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.