FDA Device recall Z-2890-2026
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic by Siemens Healthcare Diagnostics, citing 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 E….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2890-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-06 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Reason
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.
Identifiers
| code_info | All Lots within expiry/UDI: 00630414611099 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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- Atellica CH Revised C-Reactive Protein (RCRP)
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2890-2026%22
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