03ba9f5b_port___Week_of_August_15__2012__Classification
[Product Type] Devices [Product Description] 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. [Code Info] Version 5.0 and Version 5.0 Service Pack 1 through 4 [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 page. [Recalling Firm] Siemens Healthcare Diagnostics, Inc. [Classification] 
Class II
C l a s s I I
C l a s s I I I
C l a s s I
Enforcement Report - Week of August 15, 2012