Z-0823-2014Class II

Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a...

Name: Z-0823-2014 Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-10-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-10-30 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2013-10-30. FDA classified it as Class II and gives the reason as "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.)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0823-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-30
Posted: 2014-01-24
Terminated: 2014-12-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.)
Root cause tag: software
FDA root cause: 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.
Product codes and lots: CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0823-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)