Recall Z-0545-2007 ยท CDD Radioassay, Vitamin B12
Siemens Medical Solutions Diagnostics
Sample Management System software for in vitro diagnostic testing Product # 030102-03
| Date | Mar 1, 2007 (initiated Jan 15, 2007) |
| Status | Terminated |
| Reason | Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report. |
| Root cause | Other |
| Action | A recall communication was sent on 1/15/2007 to all customers by fax. |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.