FDA Device recall Z-1615-2016
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers
- FDA Device
- Class III
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class III recall of ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers by Siemens Healthcare Diagnostics, citing the firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1615-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-30 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Reason
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Identifiers
| code_info | All serial numbers |
|---|
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-1615-2016%22
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