Recall Z-1204-2017— Siemens Healthcare Diagnostics, Inc.

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2016-11-29, terminated 2018-06-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-11-29

Terminated

2018-06-07

Firm location

Tarrytown, NY, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.