FDA Device recall Z-3063-2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) by Siemens Healthcare Diagnostics, citing the potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3063-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-29 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Reason
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
Identifiers
| code_info | Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3063-2024%22
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