Device product
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Z-2912-2016
Product summary
- Event
- Event 75108
- Status
- Terminated
- Classification
- Class III
- Quantity
- 689 cartridges
- Official record key
device-enforcement:Z-2912-2016
Official wording
Reason: Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
Code information: Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Distribution pattern: Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia
Derived failure modes
-
Unknown
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge