Atellica CH Urine Albumin REF: 11537225 — Class II medical device recall Z-2890-2026
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2026-08-12, distributed nationwide. Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atel
| Recall number | Z-2890-2026 |
|---|---|
| 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 | 2026-07-06 |
| Classified | 2026-08-05 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, BS, 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, SI, SK, ZA |
| Quantity | 7,018 units |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414611099 |
| Model numbers | 11537225 |
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Reason for recall
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
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-2890-2026. 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.