Recall Z-1797-2020 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
| Date | Feb 27, 2020 |
| Status | Terminated |
| Reason | Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Correction notification letter dated 2/27/20 was sent to customers. The purpose of this communication is to inform you of the issues listed in Table 2 below, that can occur on the Atellica CH 930 Analyzer, installed with Atellica Solution software (SW) versions v1.21.0 SP1 or lower and provide instructions on actions your laboratory must take. These issues will be corrected in SW v1.22.0 and v1.21.11, which will be available soon. Actions to be Taken by the Customer The following actions must be taken until your system has been updated to software version v1.22.0 (or |
| Quantity | 1807 |
| Distribution | US Nationwide. Global distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc., Dec 11, 2015 |