FDA Device recall Z-1797-2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
- FDA Device
- Class II
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower by Siemens Healthcare Diagnostics, citing 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 o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1797-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-27 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
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.
Identifiers
| code_info | UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00…UDI: 00630414002163; All systems with software version v1.21.0 SP1 or lower Serial Numbers: CM01702 CM01708 CM00184 CM00196 CM01051 CM01467 CM00770 CM00815 CM00983 CM01053 CM00802 CM01004 CM01903 CM00526 CM00635 CM00809 CM00733 CM00735 CM01045 CM01050 CM01052 CM01059 CM00420 CM00632 CM00633 CM00209 CM00210 CM01799 CM01590 CM01612 CM01047 CM01048 CM00859 CM00865 CM01624 CM01626 CM00829 CM00830 CM00651 CM00654 CM01603 CM01608 CM01695 CM01701 CM00749 CM00786 CM01567 CM01569 CM01682 CM01683 CM00773 CM01431 CM01474 CM01583 CM01598 CM01602 CM00148 CM00151 CM00152 CM01907 CM01738 CM01739 CM01105 CM00799 CM00800 CM01823 CM01917 CM01409 CM01410 CM01588 CM01600 CM01274 CM01306 CM00947 CM00948 CM01660 CM01661 CM00812 CM00828 CM00820 CM01593 CM01594 CM01585 CM01599 CM01058 CM00421 CM00606 CM00331 CM00333 CM01133 CM01149 CM01619 CM01191 CM01200 CM00769 CM00858 CM01237 CM01259 CM00797 CM00798 CM0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2020%22
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