Sample Management System software for in vitro diagnostic testing Product # 030102-03
FDA Recall Z-0545-2007 · Posted 2007-03-01
Recalling FirmSiemens Medical Solutions Diagnostics
Recall StatusTerminated
Product CodeCDD
Date Initiated2007-01-15
Date Terminated2008-01-18
Product Quantity87 units
Reason for Recall
Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
Firm Action
A recall communication was sent on 1/15/2007 to all customers by fax.
Root Cause
Other
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.