FDA Device recall Z-0863-2021
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens
- FDA Device
- Class II
- terminated
- Published 2021-01-20
On 2021-01-20 the FDA classified a Class II recall of Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens by Siemens Healthcare Diagnostics, citing multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0863-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-02 |
| Published | 2021-01-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: 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 in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
Identifiers
| code_info | Software (SW) versions V1.23.2 (SMN 11469032) or lower |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0863-2021%22
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