Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0823-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 30, 2013

Date Posted: January 29, 2014

Recall Number: Z-0823-2014

Event ID: 66694

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.)

Status: Terminated

Product Quantity: 40

Code Information:

CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.

Distribution Pattern:

US Distribution in the states of: MN, NJ, and NV.

Voluntary or Mandated:

Voluntary: Firm initiated