Z-1204-2017Class II

CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a...

Name: Z-1204-2017 CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-11-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-11-29 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager... on 2016-11-29. FDA classified it as Class II and gives the reason as "There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1204-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Posted: 2017-02-15
Terminated: 2018-06-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CentraLink Data Management System Software Versions: v13x,v14x,v15x 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. Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: There is a remote possibility CentraLink may download an order to the ADVIA Automation System without specifying the sample type. This can occur when an order is received from the LIS without a sample type, requiring that the sample type be set in CentraLink based on the sample type of the test in the order.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Healthcare Diagnostics, sent an Urgent Medical Device Correction Notice dated November 29, 2016, to all affected customers within the USA, and and issued notices titled "Urgent Field Safety Notices" to their international customers. Effectiveness Check Forms were also sent to the affected customers. Siemens recommends the LIS specify the sample type in the work order. The CentraLink system is designed to operate in an environment in which the sample type is specified in the work order that is downloaded from the LIS. A Siemens Technical Support Representative will contact affected customers to review your CentraLink configuration. If your LIS does not include sample type information in the sample orders downloaded to CentraLink and Pre-Tests assigned by sample type are configured on the ADVIA Automation System your representative will update your configuration. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (914) 631-8000.
Quantity in commerce: 3,893 units
Distribution: Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ, CA, CO, CT FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA and WV; and to the country of Canada and others.
Product codes and lots: Product codes: 10485061, 10484212, 10485064, 10483439, 10471393, 10484552, 10814296, 10815474, 11220480, 10481936, 10481937, 10481938, 10482170, 10482936, 10483437, 10483438, 10483440, 10484211, 10484213, 10485060, 10485062, 10485063, 10703007, 10703008, 10711638, 10711639, 10711640, 10711641, 10711643, 10811596, 10811597, 10811598, 10811599, 10811601, 10811741, 10811742, 10811743, 10814298, 10814877, 10814880, 10814881, 10815694, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181, 10819760, 10819943, 11219840, 11219841.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1204-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1204-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-15

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)