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U.S. Department of Health and Human Services

Class 2 Device Recall SMS

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 Class 2 Recall
SMS
see related information
Date Posted March 01, 2007
Recall Status1 Terminated on January 18, 2008
Recall Number Z-0545-2007
Recall Event ID 37160
Premarket Notification
510(K) Number
Product Classification Radioassay, Vitamin B12 - 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, New Jersey 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
DESIGN: Software Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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