Recall Z-0072-2017 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur XPT Immunoassay System
| Date | Apr 28, 2016 |
| Status | Terminated |
| Reason | The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted. |
| Root cause | Under Investigation by firm |
| Action | Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service en |
| Quantity | 292 units Total (3 domestically & 289 internationally) |
| Distribution | Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141999 | ADVIA CENTAUR TSH Siemens Healthcare Diagnostics, Inc., Apr 22, 2015 |