FDA Device

Sample Management System software for in vitro diagnostic testing Product # 030102-03

Hazard

Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.

What You Should Do

Remedy

A recall communication was sent on 1/15/2007 to all customers by fax.

Products

Sample Management System software for in vitro diagnostic testing Product # 030102-03
Brand
Siemens Medical Solutions Diagnostics
UPC
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

Units Affected

87 units