Recall Z-0615-2016 ยท DHA System, Test, Human Chorionic Gonadotropin
Siemens Healthcare Diagnostics Inc
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
| 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 | 590 |
| 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
| K060548 | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK Dade Behring, Inc., Apr 6, 2006 |