Recall Z-1537-2017 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Co
| Date | Feb 23, 2017 (initiated Feb 2, 2017) |
| Status | Terminated |
| Reason | Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an Urgent Medical Device Correction letter ( UMDC) dated February 2, 2017. An Urgent Field Safety Notice letter ( UFSN) dated February 2017, was also sent to foreign customers. Customers must follow instructions in the UMDC and UFSN letters. For questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795. |
| Quantity | US: 17 units; Foreign: 712 units |
| Distribution | Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hung |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141999 | ADVIA CENTAUR TSH Siemens Healthcare Diagnostics, Inc., Apr 22, 2015 |