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U.S. Department of Health and Human Services

Class 2 Device Recall SMS

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  Class 2 Device Recall SMS see related information
Date Initiated by Firm January 15, 2007
Date Posted March 01, 2007
Recall Status1 Terminated 3 on January 18, 2008
Recall Number Z-0545-2007
Recall Event ID 37160
510(K)Number K023741  
Product Classification software for in vitro diagnostic testing - Product Code CDD
Product Sample Management System software for in vitro diagnostic testing
Product # 030102-03
Code Information SMS Product # 030102-03, Serial #s D0314, D0280, E0545, C0081, C0026, D0384, D0244, E0515, E0511, E0550, C0222, C0223, C0207, D0355, E0517, C0219R,C0221, B0021, B0022, D0353, E0503, E0446, C0193, E0471, E0566, D0299, E0513, D0281, D0356, C0101, C0203, C0205, B0027, E0426, E0440, C0176, C0182, E0504, C0220, E0495, D0272, E0490, E0534, C0208, C0218, C0191, E0473, D0296, C0168, E0470, C0199, D0330, C0206, D0313, C0192, E0509, D0369, E0492, E0493, D0304, D0310, D0311, E0563, D0331, C0204, E0589, D0327, D0275, E0514, E0443, E0444, D0243, C0216, C0217, E0546, E0548, C0209, E0450, D0291, D0276, D0273, D0332, E0508, B0033, E0449, E0516, D0357
Recalling Firm/
Manufacturer		 Siemens Medical Solutions Diagnostics
62 Flanders-Bartley Rd
Flanders NJ 07836-4715
For Additional Information Contact Christopher clegg
973-927-2828 Ext. 4336
Manufacturer Reason
for Recall		 Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
FDA Determined
Cause 2		 Other
Action A recall communication was sent on 1/15/2007 to all customers by fax.
Quantity in Commerce 87 units
Distribution Worldwide, including USA, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and United Kingdom.
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.
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