Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on t
FDA device recall Z-0614-2016 · posted 2016-01-07 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- Action taken
- Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- NQD
- Quantity affected
- 78
- Distribution
- Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Irela
- Date initiated
- 2015-11-11
- Date posted
- 2016-01-07
- Date terminated
- 2016-09-23
- Location
- Norwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924) | Dade Behring, Inc. | 2006-12-26 |