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 2026-01-14; 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: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…

Name: FDA Recall Record — Roche Diagnostics Operations, Inc.
Creator: Argus HQ
Published: 2026-01-14
License: https://argushq.ai/methodology

Event date: 2026-01-14 00:00:00Z
Observed: 2026-07-16 23:20:07Z
Source ID: Z-1009-2026
Payload hash: 968fae70f7b8e60dd48d0b0e…

Summary

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment. 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 2026-01-14; 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 (2026). Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-1009-2026

MLA

"Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-1009-2026.

Chicago

Argus HQ Research. "Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-1009-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_roche_diagnostics_operations_inc_z_1009_2026_2026,
  title = {Roche Diagnostics Operations, Inc. — Class II recall: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with s…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-roche-diagnostics-operations-inc-z-1009-2026},
  note = {Accessed: July 23, 2026}
}

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