Has Siemens Healthcare Diagnostics, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic

Name: FDA Recall Record — Siemens Healthcare Diagnostics, Inc.
Creator: Argus HQ
Published: 2026-08-12
License: https://argushq.ai/methodology

Event date: 2026-08-12 00:00:00Z
Observed: 2026-08-19 04:20:39Z
Source ID: Z-2890-2026
Payload hash: 373d982006fe1193b3964f69…

Summary

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 fai… Status: Ongoing.

Entities

Siemens Healthcare Diagnostics, Inc.

View source record ↗

Frequently asked questions

Has Siemens Healthcare Diagnostics, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-08-12; Argus observed and indexed it on 2026-08-19.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2890-2026

MLA

"Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2890-2026.

Chicago

Argus HQ Research. "Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2890-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_siemens_healthcare_diagnostics_inc_z_2890_2026_2026,
  title = {Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2890-2026},
  note = {Accessed: August 19, 2026}
}

Informational only. Not legal, financial, or medical advice.