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Class 2 Device Recall EasyLink Informatics System |
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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
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Product Classification |
Information system - Product Code JJE
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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
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For Additional Information Contact |
Aydee Crawford 302-631-6311
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Manufacturer Reason for Recall |
Sample ID and Patient results could be associated with the wrong patient
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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
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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.
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510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = DADE BEHRING, INC.
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