Has Abbott Molecular, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 12 total FDA actions tied to Abbott Molecular, Inc.: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-04-12; Argus observed and indexed it on 2026-07-16.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…

Name: FDA Recall Record — Abbott Molecular, Inc.
Creator: Argus HQ
Published: 2023-04-12
License: https://argushq.ai/methodology

Event date: 2023-04-12 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1349-2023
Payload hash: 587b701c5c904dfc436fffc0…

Summary

The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results. Status: Ongoing.

Entities

Abbott Molecular, Inc.

View source record ↗

Frequently asked questions

Has Abbott Molecular, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 12 total FDA actions tied to Abbott Molecular, Inc.: 0 warning letters, 12 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2023-04-12; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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

Cite this record

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

APA

Argus HQ Research (2023). Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1349-2023

MLA

"Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-molecular-inc-z-1349-2023.

Chicago

Argus HQ Research. "Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1349-2023.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_molecular_inc_z_1349_2023_2023,
  title = {Abbott Molecular, Inc. — Class II recall: Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1349-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.