What is the most recent FDA action on file for Roche Molecular Systems, Inc.?

February 15, 2023. Argus HQ ingests new FDA enforcement records daily.

Has Roche Molecular Systems, Inc. had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Roche Molecular Systems, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Roche Molecular Systems, Inc. had?

Argus HQ has recorded 3 FDA events for Roche Molecular Systems, Inc.: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Roche Molecular Systems, Inc.'s Complete FDA Record

FDA action counts

Total FDA actions	3
Warning letters	0
Recalls	3
Approval records	0
Form 483 inspection citations	0
Most recent action	February 15, 2023

Key takeaway: Argus HQ has recorded 3 FDA events for Roche Molecular Systems, Inc.: 0 warning letters, 3 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-02-15 to 2023-02-15. The most severe rating Argus HQ has assigned across this history is "high". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Roche Molecular Systems, Inc. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2023-02-15, Argus HQ recorded an FDA recall for Roche Molecular Systems, Inc., rated "high" severity in Argus HQ's classification: Roche Molecular Systems, Inc. — Class II recall: cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/880…. On 2023-02-15, Argus HQ recorded an FDA recall for Roche Molecular Systems, Inc., rated "high" severity in Argus HQ's classification: Roche Molecular Systems, Inc. — Class II recall: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the co…. On 2023-02-15, Argus HQ recorded an FDA recall for Roche Molecular Systems, Inc., rated "high" severity in Argus HQ's classification: Roche Molecular Systems, Inc. — Class II recall: cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

What is the most recent FDA action on file for Roche Molecular Systems, Inc.?: February 15, 2023. Argus HQ ingests new FDA enforcement records daily.
Has Roche Molecular Systems, Inc. had product recalls?: Yes, 3 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Roche Molecular Systems, Inc. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Roche Molecular Systems, Inc. had?: Argus HQ has recorded 3 FDA events for Roche Molecular Systems, Inc.: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Feb 15, 2023

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2023). Roche Molecular Systems, Inc.'s Complete FDA Record. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/roche-molecular-systems-inc

MLA

"Roche Molecular Systems, Inc.'s Complete FDA Record." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/company/roche-molecular-systems-inc.

Chicago

Argus HQ Research. "Roche Molecular Systems, Inc.'s Complete FDA Record." Digital Empire Holdings LLC. Accessed July 17, 2026. https://argushq.ai/company/roche-molecular-systems-inc.

BibTeX

@misc{argushq_argushq_ai_company_roche_molecular_systems_inc_2023,
  title = {Roche Molecular Systems, Inc.'s Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/roche-molecular-systems-inc},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗