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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension EXL

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  Class 2 Device Recall Dimension EXL see related information
Date Initiated by Firm September 30, 2008
Date Posted January 13, 2009
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-0581-2009
Recall Event ID 49608
510(K)Number K073604  
Product Classification Radioimmunoassay, free thyroxine - Product Code JJE
Product Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.

The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use.
Code Information Software versions 8.5.1 and 8.5.1SP3.
Recalling Firm/
Manufacturer		 Dade Behring, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Elaine Kindell
888-899-2896
Manufacturer Reason
for Recall		 Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.
FDA Determined
Cause 2		 Software design
Action The recalling firm notified consignees by telephone to inform them of the problem. A follow-up letter, "Urgent Field Safety Notice" dated 9/30/08 was issued with information describing the problem, the possible impact of an occluded wash probe on assay results, and emphasizing regular performance of routine wash probe maintenance as detailed in the operator guide to prevent wash probe occlusion. For questions, please contact the Siemens Technical Solution Center at 800-441-9250.
Quantity in Commerce 57 units
Distribution Nationwide Distribution including states of AR, CA, CO, IA, ID, IL, IN, LA, MD, MI, MO, MS, NC, NE, OH, OK, PA, SD, TN, TX, VA, and WI.
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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