Z-0987-2015Class II

ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The...

Name: Z-0987-2015 ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-12-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-12-16 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution... on 2014-12-16. FDA classified it as Class II and gives the reason as "Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0987-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Posted: 2015-01-15
Terminated: 2016-10-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: 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: Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.
FDA root cause: Under Investigation by firm
Action: A Siemens service provider visited each site to verify and/or update customer configuration on the ADVIA Chemistry XPT and CentraLink Systems to ensure proper reporting of results. An Urgent Medical Device Correction letter was issued on December 16, 2014 to all affected customers. Customers were also provided a Customer Bulletin providing instructions on how configuration setting should remain.
Quantity in commerce: 7
Distribution: Distributed in the state of WA.
Product codes and lots: CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0987-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

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)