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 2024-11-06; 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 STI AMP Kit, used with the Alinity m System, product codes: a)…

Name: FDA Recall Record — Abbott Molecular, Inc.
Creator: Argus HQ
Published: 2024-11-06
License: https://argushq.ai/methodology

Event date: 2024-11-06 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-0234-2025
Payload hash: 977ef376b8d1151659ae085d…

Summary

Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the… 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 2024-11-06; 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 (2024). Abbott Molecular, Inc. — Class II recall: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-0234-2025

MLA

"Abbott Molecular, Inc. — Class II recall: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-abbott-molecular-inc-z-0234-2025.

Chicago

Argus HQ Research. "Abbott Molecular, Inc. — Class II recall: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-0234-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_molecular_inc_z_0234_2025_2024,
  title = {Abbott Molecular, Inc. — Class II recall: Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a)…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-0234-2025},
  note = {Accessed: July 23, 2026}
}

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