FDA Device recall Z-1484-2026
Atellica CH Urine Albumin (UAlb)
- FDA Device
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Atellica CH Urine Albumin (UAlb) by Siemens Healthcare Diagnostics, citing falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1484-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-20 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Reason
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Identifiers
| code_info | Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Siemens Healthcare Diagnostics
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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
FDA Device · Class II · 2026-08-12 · Siemens Healthcare Diagnostics
All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2026%22
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