Siemens Healthcare Diagnostics, Inc. recalls EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with p…

Recall date

April 29, 2015

Source

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

Recall number

Z-1942-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Canada, Switzerland, Germany, Denmark, Spain, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Norway, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan.

Why it was recalled

System Limitations and Software Issues related to the following features: Custom reference ranges, User-initiated sample and result actions, Auto-verification and quality control rules, and Sample reports.

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

What was recalled

EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.