DeviceSignal · Recall classified
Siemens Healthcare Diagnostics, Inc.
FDA classified a device recall on 2026-08-05 · Class II · Z-2890-2026
EventRecall classified
Effective2026-08-05
ClassificationClass II
On 2026-08-05 the FDA classified a device recall from Siemens Healthcare Diagnostics, Inc. as Class II. Product: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. Recall Z-2890-2026. The firm initiated it on 2026-07-06. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2890-2026
- Classification
- Class II
- Classified on
- 2026-08-05
- Initiated on
- 2026-07-06
- Firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Product
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2890-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
6bf64a05a310156d1be98db173bdefca04fb19c03ed84479de912785398b0fe0- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)