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

Yes. Argus HQ has recorded 4 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 4 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 2026-07-15; Argus observed and indexed it on 2026-07-23.

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 Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

Name: FDA Recall Record — Siemens Healthcare Diagnostics, Inc.
Creator: Argus HQ
Published: 2026-07-15
License: https://argushq.ai/methodology

Event date: 2026-07-15 00:00:00Z
Observed: 2026-07-23 04:20:40Z
Source ID: Z-2703-2026
Payload hash: 4e420bcd5d39abb240159bc5…

Summary

The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. 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 4 total FDA actions tied to Siemens Healthcare Diagnostics, Inc.: 0 warning letters, 4 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 2026-07-15; Argus observed and indexed it on 2026-07-23.
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 Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2703-2026

MLA

"Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2703-2026.

Chicago

Argus HQ Research. "Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2703-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_siemens_healthcare_diagnostics_inc_z_2703_2026_2026,
  title = {Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2703-2026},
  note = {Accessed: July 23, 2026}
}

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