FDAFDA · Food and drugs·Recall number Z-2172-2012
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
Published August 15, 2012 · Recall initiated: June 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink systems application of the configured result number format. The problem is encountered when the result number format configured on the Sysmex CA-7000 or CA-1500 coagulation analyzer does not match the EasyLink system settings on the following
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.
- Lot
- Version 5.0 and Version 5.0 Service Pack 1 through 4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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