Recall Z-0609-2016 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics Inc
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
| 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 | 5558 |
| 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
| K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. Dade Behring, Inc., Sep 8, 2005 |