Recall Z-1586-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
| Date | Feb 26, 2018 |
| Status | Terminated |
| Reason | When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers |
| Root cause | Software design |
| Action | Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally. |
| Distribution | FL and France Spain Sweden United Kingdom Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics, Inc., Nov 20, 2015 |