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fda_recall · device_recall · high

Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Event date
2025-08-13 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-2237-2025
Payload hash
2bd9ac4745869a0deac52096

Summary

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. Status: Ongoing.

Frequently asked questions

Has Becton, Dickinson and Company, BD Bio Sciences had other FDA enforcement actions?
Yes. Argus HQ has recorded 10 total FDA actions tied to Becton, Dickinson and Company, BD Bio Sciences: 0 warning letters, 10 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 2025-08-13; 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). Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-becton-dickinson-and-company-bd-bio-sciences-z-2237-2025
MLA
"Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/events/fda-recall-becton-dickinson-and-company-bd-bio-sciences-z-2237-2025.
Chicago
Argus HQ Research. "Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-becton-dickinson-and-company-bd-bio-sciences-z-2237-2025.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_becton_dickinson_and_company_bd_bio_sciences_z_2237_2025_2025,
  title = {Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-becton-dickinson-and-company-bd-bio-sciences-z-2237-2025},
  note = {Accessed: July 23, 2026}
}

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