Does Argus HQ track new FDA actions for Abbott Laboratories automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Abbott Laboratories is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Abbott Laboratories?

15 total: 0 warning letters, 15 recalls, 0 approval records, and 0 Form 483 inspection citations.

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

December 24, 2025. Argus HQ ingests new FDA enforcement records daily.

Has Abbott Laboratories had product recalls?

Yes, 15 recalls on file. See the full history below for each one.

Abbott Laboratories's Complete FDA Record

FDA action counts

Total FDA actions	15
Warning letters	0
Recalls	15
Approval records	0
Form 483 inspection citations	0
Most recent action	December 24, 2025

Key takeaway: Argus HQ has recorded 15 FDA events for Abbott Laboratories: 0 warning letters, 15 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-01-25 to 2025-12-24. 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. Abbott Laboratories has 15 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 2025-12-24, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20. On 2025-11-19, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalo…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08…. On 2024-08-28, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Alinity hq Analyzer, REF: 09P68-01. On 2024-04-10, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.. On 2024-01-17, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56…. On 2024-01-17, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is…. On 2024-01-17, Argus HQ recorded an FDA recall for Abbott Laboratories, rated "high" severity in Argus HQ's classification: Abbott Laboratories — Class II recall: Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is….

Frequently asked questions

Does Argus HQ track new FDA actions for Abbott Laboratories automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Abbott Laboratories is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Abbott Laboratories?: 15 total: 0 warning letters, 15 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Abbott Laboratories?: December 24, 2025. Argus HQ ingests new FDA enforcement records daily.
Has Abbott Laboratories had product recalls?: Yes, 15 recalls on file. See the full history below for each one.

Every FDA action tied to this company, the week it happens.

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

Verified from FDA.gov · Last updated: Dec 24, 2025

Cite this record

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

APA

Argus HQ Research (2025). Abbott Laboratories's Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott-laboratories

MLA

"Abbott Laboratories's Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/abbott-laboratories.

Chicago

Argus HQ Research. "Abbott Laboratories's Complete FDA Record." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/abbott-laboratories.

BibTeX

@misc{argushq_argushq_ai_company_abbott_laboratories_2025,
  title = {Abbott Laboratories's Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/abbott-laboratories},
  note = {Accessed: July 17, 2026}
}

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