Z-1957-2015Class II

CentraLink" Data Management System; software is a network solution provider and multi-system data manager for...

Name: Z-1957-2015 CentraLink" Data Management System; software is a network solution provider and multi-system data manager for...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-05-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-05-19 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS)... on 2015-05-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1957-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-19
Posted: 2015-07-02
Terminated: 2018-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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 root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

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)