Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0987-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

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 Classification:

Class II

Date Initiated: December 16, 2014
Date Posted: January 21, 2015
Recall Number: Z-0987-2015
Event ID: 70078
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.

Status: Terminated
Product Quantity: 7
Code Information:

CentraLink" Data Management System V14x Catalog Numbers: 10817209, 10818262

Distribution Pattern:

Distributed in the state of WA.

Voluntary or Mandated:

Voluntary: Firm initiated