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fda_recall · device_recall · high

Becton Dickinson & Co. — Class II recall: BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20…

Event date
2024-10-16 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-0026-2025
Payload hash
6cf5c765fc97f34f94bb5206

Summary

Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is incl… Status: Ongoing.

Frequently asked questions

Has Becton Dickinson & Company had other FDA enforcement actions?
Yes. Argus HQ has recorded 96 total FDA actions tied to Becton Dickinson & Company: 0 warning letters, 96 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 2024-10-16; 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). Becton Dickinson & Co. — Class II recall: BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-becton-dickinson-and-co-z-0026-2025
MLA
"Becton Dickinson & Co. — Class II recall: BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-becton-dickinson-and-co-z-0026-2025.
Chicago
Argus HQ Research. "Becton Dickinson & Co. — Class II recall: BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-becton-dickinson-and-co-z-0026-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_becton_dickinson_and_co_z_0026_2025_2024,
  title = {Becton Dickinson & Co. — Class II recall: BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-becton-dickinson-and-co-z-0026-2025},
  note = {Accessed: July 23, 2026}
}

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