Recall Z-2242-2012— Siemens Healthcare Diagnostics, Inc.

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2012-05-29, terminated 2014-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The EasyLink Informatics System is classified as a data calculator and processing module for use with in vitro diagnostic devices. The EasyLink is included with the Dimension Vista System and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.. Reason: When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient.

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-05-29

Terminated

2014-04-10

Firm location

Newark, DE, United States

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