Has Roche Diagnostics Operations, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Roche Diagnostics Operations, Inc.: 0 warning letters, 6 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 2024-11-27; Argus observed and indexed it on 2026-07-16.

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

Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…

Name: FDA Recall Record — Roche Diagnostics Operations, Inc.
Creator: Argus HQ
Published: 2024-11-27
License: https://argushq.ai/methodology

Event date: 2024-11-27 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-0489-2025
Payload hash: 7ddd3ddee2f1c1dfd46c95be…

Summary

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) Status: Ongoing.

Entities

Roche Diagnostics Operations, Inc.

View source record ↗

Frequently asked questions

Has Roche Diagnostics Operations, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 6 total FDA actions tied to Roche Diagnostics Operations, Inc.: 0 warning letters, 6 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 2024-11-27; Argus observed and indexed it on 2026-07-16.
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 (2024). Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0489-2025

MLA

"Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0489-2025.

Chicago

Argus HQ Research. "Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0489-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_roche_diagnostics_operations_inc_z_0489_2025_2024,
  title = {Roche Diagnostics Operations, Inc. — Class II recall: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for u…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0489-2025},
  note = {Accessed: July 23, 2026}
}

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