EasyLink Informatic System is included with the Dimension Vista System — recall Z-2242-2012
U.S. FDA — Device Enforcement · United States · 2012-05-29 · Class II
As described by U.S. FDA — Device Enforcement: 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 analyte
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and
Reported risk: 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
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