Atlas FDA

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

FDA device recall Z-0545-2007 · posted 2007-03-01 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions Diagnostics
Reason for recall
Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
Action taken
A recall communication was sent on 1/15/2007 to all customers by fax.
Root cause
Other
Status
Terminated
Product code
CDD
Quantity affected
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, Mexi
Date initiated
2007-01-15
Date posted
2007-03-01
Date terminated
2008-01-18
Location
Flanders, NJ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.