Skip to main content

fda_recall · device_recall · high

Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Event date
2025-12-24 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-0961-2026
Payload hash
3b7c942eddd837e305f6130f…

Summary

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for… Status: Ongoing.

Entities

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 2025-12-24; 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 Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-laboratories-z-0961-2026
MLA
"Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-abbott-laboratories-z-0961-2026.
Chicago
Argus HQ Research. "Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-laboratories-z-0961-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_laboratories_z_0961_2026_2025,
  title = {Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-laboratories-z-0961-2026},
  note = {Accessed: July 23, 2026}
}

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

Abbott Laboratories — Class II recall: Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 · Argus HQ