Recall Z-2913-2016 ยท JFS Coulometric, Chloride
Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
| Date | Sep 30, 2016 (initiated Sep 2, 2016) |
| Status | Terminated |
| Reason | Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge |
| Root cause | Under Investigation by firm |
| Action | 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 repr |
| Quantity | 6638 cartridges |
| Distribution | Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN Siemens Healthcare Diagnostics, Aug 15, 2011 |