Recall Z-1587-2018 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica Solution and Atellica Sample Handler Prime 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
| K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica Siemens Healthcare Diagnostics, Mar 9, 2017 |