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 medium 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 · medium

Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catal…

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 04:20:44Z
Source ID: Z-2880-2026
Payload hash: b76568123aa0da913684b73f…

Summary

Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodiu… 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 medium 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 III recall: Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catal…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2880-2026

MLA

"Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catal…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2880-2026.

Chicago

Argus HQ Research. "Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catal…." Digital Empire Holdings LLC. Accessed August 19, 2026. https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2880-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_siemens_healthcare_diagnostics_inc_z_2880_2026_2026,
  title = {Siemens Healthcare Diagnostics, Inc. — Class III recall: Syva Emit Disopyramide Assay  Enzyme Immunoassay, Lidocaine  SMN 10445370  Catal…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-siemens-healthcare-diagnostics-inc-z-2880-2026},
  note = {Accessed: August 19, 2026}
}

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