Siemens Healthcare Diagnostics, Inc. recalls CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instr…

Recall date

May 19, 2015

Source

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

Recall number

Z-1957-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution - Nationwide Distribution and to the countries of : Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Saudi Arabia, Spain, Switzerland and United Kingdom.

Why it was recalled

Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.

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 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.