Recall Z-2912-2016
Siemens Healthcare Diagnostics Inc · initiated September 2, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Codes / lots: Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016
Reason for recall
Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge
FDA-determined 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.
Details
- Recall number
- Z-2912-2016
- Initiated
- September 2, 2016
- Posted by FDA
- September 30, 2016
- Terminated
- August 7, 2017
- Product code
- JFS – Coulometric, Chloride
- Quantity
- 689 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
- Recalling firm
- Siemens Healthcare Diagnostics Inc, Norwood, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2913-2016 Class III | Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322…Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405… | 09/02/2016Terminated |