Atellica CH Urine Albumin Assay
Siemens recalls Atellica CH Urine Albumin assay over falsely depressed UN_c and A1c_E results and QC failures.
Contact Siemens Healthcare Diagnostics for instructions on returning or replacing the affected Atellica CH Urine Albumin assay, REF 11537225, and discontinue use of the product until corrective action is completed.
Recall at a glance
- Quantity recalled
- 7018 units
Why it was recalled
Siemens Healthcare Diagnostics is recalling the Atellica CH Urine Albumin (UAlb) in vitro diagnostic test, REF 11537225, because processing UAlb tests on Atellica CH and Atellica CI analyzers may cause falsely depressed Urea Nitrogen (UN_c) and Enzymatic Hemoglobin A1c (A1c_E) results, as well as increased cuvette QC failures and delayed results.
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 REF: 11537225, in vitro diagnostic
| Lot code | UDI-DI |
|---|---|
| – | 00630414611099 |
| All Lots within expiry/UDI: 00630414611099 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Siemens Healthcare Diagnostics, Inc.
Editorial summary by Recall Canary · summary updated 2026-08-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification