Has Abbott Point Of Care Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to Abbott Point Of Care Inc.: 0 warning letters, 7 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 2025-09-24; 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 Point Of Care Inc. — Class II recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.

Name: FDA Recall Record — Abbott Point Of Care Inc.
Creator: Argus HQ
Published: 2025-09-24
License: https://argushq.ai/methodology

Event date: 2025-09-24 00:00:00Z
Observed: 2026-07-16 23:20:09Z
Source ID: Z-2582-2025
Payload hash: 7cfa6934e0664bd7e05b4767…

Summary

Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. Status: Ongoing.

Entities

Abbott Point Of Care Inc.

View source record ↗

Frequently asked questions

Has Abbott Point Of Care Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to Abbott Point Of Care Inc.: 0 warning letters, 7 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 2025-09-24; 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 Point Of Care Inc. — Class II recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-point-of-care-inc-z-2582-2025

MLA

"Abbott Point Of Care Inc. — Class II recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-point-of-care-inc-z-2582-2025.

Chicago

Argus HQ Research. "Abbott Point Of Care Inc. — Class II recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-point-of-care-inc-z-2582-2025.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_abbott_point_of_care_inc_z_2582_2025_2025,
  title = {Abbott Point Of Care Inc. — Class II recall: i-STAT CG4+ cartridge (white). List Number: 03P85-25.},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-point-of-care-inc-z-2582-2025},
  note = {Accessed: July 23, 2026}
}

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