FDA Device recall Z-0782-2019
Atellica CH 930 Analyzer
- FDA Device
- Class II
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class II recall of Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics, citing multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0782-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-26 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Reason
Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
Identifiers
| code_info | Software in V 1.14.2 and lower. |
|---|
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-0782-2019%22
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