Drug recall
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
FDA recall event 99389 · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Event ID | 99389 |
|---|---|
| Recall numbers | Z-2890-2026 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Product type | Devices |
| Products | Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 6, 2026 |
| Report date | Aug 12, 2026 |
| City | Tarrytown |
| State | NY |
| Country | United States |
| FEI number | 2432235 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: