FDA Device recall Z-1587-2018
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens by Siemens Healthcare Diagnostics, citing when more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1587-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-26 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | FL |
Product
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Reason
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Identifiers
| code_info | UDI 00630414002439 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1587-2018%22
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