FDA Enforcement History: Abbott GmbH

FDA action counts

Enforcement history

On 2024-04-10, Argus HQ recorded an FDA recall for Abbott GmbH, rated "high" severity in Argus HQ's classification: Abbott GmbH — Class II recall: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35. On 2024-04-10, Argus HQ recorded an FDA recall for Abbott GmbH, rated "high" severity in Argus HQ's classification: Abbott GmbH — Class II recall: Alinity i Anti-HCV Reagent Kit, List Number 08P0521. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott GmbH has 2 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.

Frequently asked questions

What is the most recent FDA action on file for Abbott GmbH?

April 10, 2024. Argus HQ ingests new FDA enforcement records daily.

Has Abbott GmbH had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Abbott GmbH 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 GmbH had?

Argus HQ has recorded 2 FDA events for Abbott GmbH: 0 warning letters, 2 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.

Related enforcement actions

• Abbott GmbH — Class II recall: Alinity i Anti-HCV Reagent Kit, List Number 08P0521 →
• Abbott GmbH — Class II recall: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 →

Compare with

• Abbott GmbH vs Philips North America
• Abbott GmbH vs Boston Scientific Corporation
• Abbott GmbH vs Medline Industries, LP
• Abbott GmbH vs Baxter Healthcare Corporation
• Abbott GmbH vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.