Has Abbott Diagnostics Technologies AS had product recalls?

Yes, 1 recall on file. See the full history below for each one.

Is this FDA enforcement data for Abbott Diagnostics Technologies AS 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 Abbott Diagnostics Technologies AS had?

Argus HQ has recorded 1 FDA events for Abbott Diagnostics Technologies AS: 0 warning letters, 1 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.

What is the most recent FDA action against Abbott Diagnostics Technologies AS?

The most recent FDA event Argus HQ has on file for Abbott Diagnostics Technologies AS is dated 2024-09-04, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

FDA Actions Against Abbott Diagnostics Technologies AS

Here's the summary: Argus HQ has recorded 1 FDA events for Abbott Diagnostics Technologies AS: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2024-09-04 to 2024-09-04. 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.

FDA action counts

Total FDA actions	1
Warning letters	0
Recalls	1
Approval records	0
Form 483 inspection citations	0
Most recent action	September 4, 2024

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott Diagnostics Technologies AS has 1 FDA event on file. 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 2024-09-04, Argus HQ recorded an FDA recall for Abbott Diagnostics Technologies AS, rated "high" severity in Argus HQ's classification: Abbott Diagnostics Technologies AS — Class II recall: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.. 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. 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.

Frequently asked questions

Has Abbott Diagnostics Technologies AS had product recalls?: Yes, 1 recall on file. See the full history below for each one.
Is this FDA enforcement data for Abbott Diagnostics Technologies AS 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 Abbott Diagnostics Technologies AS had?: Argus HQ has recorded 1 FDA events for Abbott Diagnostics Technologies AS: 0 warning letters, 1 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.
What is the most recent FDA action against Abbott Diagnostics Technologies AS?: The most recent FDA event Argus HQ has on file for Abbott Diagnostics Technologies AS is dated 2024-09-04, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Abbott Diagnostics Technologies AS — Class II recall: Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. →

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

Verified from FDA.gov · Last updated: Sep 4, 2024

Cite this record

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

APA

Argus HQ Research (2024). FDA Actions Against Abbott Diagnostics Technologies AS. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott-diagnostics-technologies-as

MLA

"FDA Actions Against Abbott Diagnostics Technologies AS." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/company/abbott-diagnostics-technologies-as.

Chicago

Argus HQ Research. "FDA Actions Against Abbott Diagnostics Technologies AS." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/abbott-diagnostics-technologies-as.

BibTeX

@misc{argushq_argushq_ai_company_abbott_diagnostics_technologies_as_2024,
  title = {FDA Actions Against Abbott Diagnostics Technologies AS},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/abbott-diagnostics-technologies-as},
  note = {Accessed: July 17, 2026}
}

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