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.
FDA Recall Z-2172-2012 · Posted 2012-08-09
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2012-06-07
Date Terminated2014-08-26
Product Quantity237
Reason for Recall
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
Firm Action
The firm initiated this recall on June 7, 2012 by issuing an "Urgent Field Safety Notice" to all customers who are known to have the EasyLink system and who also own and operate Sysmex CA-1500 and CA-7000 instruments. The Notice described the problem and provided recommended actions. Customers can contact 800-441-9250 for questions.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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