Recall Z-0610-2016 ยท NBC Test, Natriuretic Peptide
Siemens Healthcare Diagnostics Inc
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086
| 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 | 1157 |
| 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
| K071834 | STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM Dade Behring, Inc., Aug 17, 2007 |