Atellica CH Urine Albumin Test
Siemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
If you operate or use Atellica CH Urine Albumin test kits (Material Number 11537225), contact Siemens Healthcare Diagnostics immediately for instructions on verification of affected test results and replacement reagents. Review recent patient results for samples that may have been affected.
Recall at a glance
- Quantity recalled
- 4,885 units
Why it was recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin (UAlb) test kits (Material Number 11537225) worldwide because affected samples with urine albumin concentration above 40.0 mg/dL may falsely report results between 6.2 mg/dL and 40.0 mg/dL, potentially leading to missed or delayed diagnosis of kidney disease.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- UDI-DI
- 11537225, 00630414611099
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification