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U.S. Department of Health and Human Services

Class 2 Device Recall EasyLink Informatics System

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  Class 2 Device Recall EasyLink Informatics System see related information
Date Initiated by Firm July 03, 2007
Date Posted August 22, 2007
Recall Status1 Terminated 3 on November 07, 2007
Recall Number Z-1174-2007
Recall Event ID 38384
510(K)Number K051087  
Product Classification Information system - Product Code JJE
Product EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
Code Information Part number 1000034941
Recalling Firm/
Manufacturer		 Dade Behring, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Aydee Crawford
302-631-6311
Manufacturer Reason
for Recall		 Sample ID and Patient results could be associated with the wrong patient
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.
Quantity in Commerce 72 units
Distribution Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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