Sample Management System software for in vitro diagnostic testing Product # 030102-03
This recall has been terminated (originally issued March 1, 2007).
- Recall Initiated
- January 15, 2007
- Posted
- March 1, 2007
- Terminated
- January 18, 2008
- Recall Number
- Z-0545-2007
- Quantity
- 87 units
- Firm Location
- Flanders, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
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.
Lot / Code Info
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
Root Cause
Other
Action Taken
A recall communication was sent on 1/15/2007 to all customers by fax.