Recall Z-0611-2016 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Siemens Healthcare Diagnostics Inc
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
| Date | Jan 7, 2016 (initiated Nov 11, 2015) |
| Status | Terminated |
| Reason | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 2647 |
| Distribution | Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110303 | STRATUS CS ACUTE CARE D-DIMER Siemens Healthcare Diagnostics, May 16, 2011 |