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.
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FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics - Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2027-2025%22
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