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 2023-01-18; 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 infinity central lab, Material Number 07154003001

Name: FDA Recall Record — Roche Diagnostics Operations, Inc.
Creator: Argus HQ
Published: 2023-01-18
License: https://argushq.ai/methodology

Event date: 2023-01-18 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-0952-2023
Payload hash: ee9e5084e4fa6b8735cb5d1d…

Summary

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the… 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 2023-01-18; 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 (2023). Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0952-2023

MLA

"Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0952-2023.

Chicago

Argus HQ Research. "Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0952-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_roche_diagnostics_operations_inc_z_0952_2023_2023,
  title = {Roche Diagnostics Operations, Inc. — Class II recall: cobas infinity central lab, Material Number 07154003001},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-0952-2023},
  note = {Accessed: July 23, 2026}
}

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