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

May 21, 2025. Argus HQ ingests new FDA enforcement records daily.

Has Abbott Molecular, Inc. had product recalls?

Yes, 12 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Abbott Molecular, 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 Abbott Molecular, Inc. had?

Argus HQ has recorded 12 FDA events for Abbott Molecular, Inc.: 0 warning letters, 12 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.

Abbott Molecular, Inc.'s Complete FDA Record

FDA action counts

Total FDA actions	12
Warning letters	0
Recalls	12
Approval records	0
Form 483 inspection citations	0
Most recent action	May 21, 2025

In short: Argus HQ has recorded 12 FDA events for Abbott Molecular, Inc.: 0 warning letters, 12 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-02-01 to 2025-05-21. 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.

Enforcement history

On 2025-05-21, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reve…. On 2025-05-21, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a mul…. On 2025-04-30, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: The Alinity m System is designed to automate the steps for nucleic acid testing.…. On 2024-11-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…. On 2024-11-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a)…. On 2024-05-01, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Alinity m System, Part Number: 08N53-002. On 2024-03-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "medium" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class III recall: Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This pa…. On 2024-03-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "medium" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class III recall: In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Pr…. On 2024-03-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "medium" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class III recall: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF…. On 2023-12-06, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The A…. On 2023-04-12, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…. On 2023-02-01, Argus HQ recorded an FDA recall for Abbott Molecular, Inc., rated "high" severity in Argus HQ's classification: Abbott Molecular, Inc. — Class II recall: Alinity m System. The Alinity m System is designed to automate the steps fo….

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Abbott Molecular, Inc. has 12 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 Molecular, Inc.?: May 21, 2025. Argus HQ ingests new FDA enforcement records daily.
Has Abbott Molecular, Inc. had product recalls?: Yes, 12 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Abbott Molecular, 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 Abbott Molecular, Inc. had?: Argus HQ has recorded 12 FDA events for Abbott Molecular, Inc.: 0 warning letters, 12 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: May 21, 2025

Cite this record

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

APA

Argus HQ Research (2025). Abbott Molecular, Inc.'s Complete FDA Record. Digital Empire LLC. Retrieved from https://argushq.ai/company/abbott-molecular-inc

MLA

"Abbott Molecular, Inc.'s Complete FDA Record." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/company/abbott-molecular-inc.

Chicago

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

BibTeX

@misc{argushq_argushq_ai_company_abbott_molecular_inc_2025,
  title = {Abbott Molecular, Inc.'s Complete FDA Record},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/abbott-molecular-inc},
  note = {Accessed: July 17, 2026}
}

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