Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
- Recall Initiated
- September 2, 2016
- Posted
- September 30, 2016
- Terminated
- August 7, 2017
- Recall Number
- Z-2912-2016
- Quantity
- 689 cartridges
- Firm Location
- Norwood, MA
Reason for Recall
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Distribution
Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
Lot / Code Info
Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Root Cause
Under Investigation by firm
Action Taken
Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.