Has Abbott Laboratories had other FDA enforcement actions?

Yes. Argus HQ has recorded 15 total FDA actions tied to Abbott Laboratories: 0 warning letters, 15 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 2025-04-30; 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 Laboratories — Class II recall: Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08…

Name: FDA Recall Record — Abbott Laboratories
Creator: Argus HQ
Published: 2025-04-30
License: https://argushq.ai/methodology

Event date: 2025-04-30 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-1655-2025
Payload hash: 79344f35670eb0e73398a037…

Summary

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual. Status: Ongoing.

Entities

Abbott Laboratories

View source record ↗

Frequently asked questions

Has Abbott Laboratories had other FDA enforcement actions?: Yes. Argus HQ has recorded 15 total FDA actions tied to Abbott Laboratories: 0 warning letters, 15 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 2025-04-30; 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 (2025). Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby  Product Name: CELL-DYN Ruby  Model/Catalog Number: 08…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-laboratories-z-1655-2025

MLA

"Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby  Product Name: CELL-DYN Ruby  Model/Catalog Number: 08…." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-laboratories-z-1655-2025.

Chicago

Argus HQ Research. "Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby  Product Name: CELL-DYN Ruby  Model/Catalog Number: 08…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-laboratories-z-1655-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_laboratories_z_1655_2025_2025,
  title = {Abbott Laboratories — Class II recall: Brand Name: CELL-DYN Ruby  Product Name: CELL-DYN Ruby  Model/Catalog Number: 08…},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-laboratories-z-1655-2025},
  note = {Accessed: July 23, 2026}
}

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