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Class 3 Device Recall Dimension Integrated Chemistry Systems |
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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
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Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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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
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For Additional Information Contact |
Customer Support 800-441-9250
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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.
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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
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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. 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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