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fda_recall · device_recall · high

Abbott Molecular, Inc. — Class II recall: Alinity m System. The Alinity m System is designed to automate the steps fo…

Event date
2023-02-01 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1009-2023
Payload hash
f4f77d70a0d2122537825ffd…

Summary

The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inabili… Status: Ongoing.

Entities

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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 2023-02-01; 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: Alinity m System.      The Alinity m System is designed to automate the steps fo…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1009-2023
MLA
"Abbott Molecular, Inc. — Class II recall: Alinity m System.      The Alinity m System is designed to automate the steps fo…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-molecular-inc-z-1009-2023.
Chicago
Argus HQ Research. "Abbott Molecular, Inc. — Class II recall: Alinity m System.      The Alinity m System is designed to automate the steps fo…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1009-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_molecular_inc_z_1009_2023_2023,
  title = {Abbott Molecular, Inc. — Class II recall: Alinity m System.      The Alinity m System is designed to automate the steps fo…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-molecular-inc-z-1009-2023},
  note = {Accessed: July 23, 2026}
}

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

Abbott Molecular, Inc. — Class II recall: Alinity m System. The Alinity m System is designed to automate the steps fo… · Argus HQ