Recall Z-2256-2016 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests,
| Date | May 26, 2016 |
| Status | Terminated |
| Reason | Eight (8) issues were identified which may affect the results generated by the system software version. |
| Root cause | Under Investigation by firm |
| Action | On May 26, 2016, Siemens Healthcare Diagnostics Inc. distributed an Urgent Medical Device Correction notices to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers are advised to complete and return the Field Correction Effectiveness Check form within 30 days via fax to (312) 275-7795. For questions contact your local Siemens technical support representative. |
| Quantity | 446 units Total (3 domestically & 443 internationally) |
| Distribution | Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141999 | ADVIA CENTAUR TSH Siemens Healthcare Diagnostics, Inc., Apr 22, 2015 |