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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Integrated Chemistry Systems

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  Class 3 Device Recall Dimension Integrated Chemistry Systems see related information
Date Initiated by Firm May 27, 2014
Date Posted July 30, 2014
Recall Status1 Terminated 3 on December 15, 2014
Recall Number Z-2133-2014
Recall Event ID 68400
510(K)Number K073604  K130276  K112999  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Code Information DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
FDA Determined
Cause 2		 Employee error
Action An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.
Quantity in Commerce 15
Distribution FL LA AR IA OH OH WI IL LA KS MT
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.
510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
510(K)s with Product Code = JJE and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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