FDA Device recall Z-2027-2025
Product: Atellica CH Diluent - CONS 2 x 1.5L
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Product: Atellica CH Diluent - CONS 2 x 1.5L by Siemens Healthcare Diagnostics, citing contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2027-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-22 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Reason
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Identifiers
| code_info | Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412; |
|---|
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-2027-2025%22
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