FDA Device recall Z-0148-2020
Siemens Atellica CH 930 Analyzer
- FDA Device
- Class II
- terminated
- Published 2019-10-23
On 2019-10-23 the FDA classified a Class II recall of Siemens Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics, citing atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0148-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-30 |
| Published | 2019-10-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Reason
Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
Identifiers
| code_info | Software version: V1.19.2 and below |
|---|
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-0148-2020%22
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