Atellica CH Urine Albumin — Class II medical device recall Z-1484-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-03-11, distributed nationwide. Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above
| Recall number | Z-1484-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2026-01-20 |
| Classified | 2026-03-02 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CW, CZ, DE, DK, ES, FI, FR, GR, HK, IE, IL, IT, KR, LV, MY, NL, NO, NZ, PT, RO, SE, SG, SK, ZA |
| Quantity | 4,885 units |
| UPC / GTIN / UDI-DI | 00630414611099 |
Product
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1484-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.