Siemens Healthcare Diagnostics, Inc. recalls CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network soluti…

Recall date

November 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1204-2017

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.