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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 Recall
EasyLink Informatics System
see related information
Date Posted August 22, 2007
Recall Status1 Terminated on November 07, 2007
Recall Number Z-1174-2007
Recall Event ID 38384
Premarket Notification
510(K) Number
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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/
Dade Behring, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Aydee Crawford
Manufacturer Reason
for Recall
Sample ID and Patient results could be associated with the wrong patient
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 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.