Regulatory Record: Becton, Dickinson and Company, BD Bio Sciences

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Becton, Dickinson and Company, BD Bio Sciences has 10 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Enforcement history

On 2025-08-13, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD. On 2025-08-13, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 340335. On 2025-07-09, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Use…. On 2025-07-09, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytom…. On 2025-01-01, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 T…. On 2025-01-01, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FA…. On 2025-01-01, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787…. On 2025-01-01, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI…. On 2025-01-01, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181. On 2024-10-09, Argus HQ recorded an FDA recall for Becton, Dickinson and Company, BD Bio Sciences, rated "high" severity in Argus HQ's classification: Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSD….

Frequently asked questions

How many FDA actions has Becton, Dickinson and Company, BD Bio Sciences had?

Argus HQ has recorded 10 FDA events for Becton, Dickinson and Company, BD Bio Sciences: 0 warning letters, 10 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Becton, Dickinson and Company, BD Bio Sciences?

The most recent FDA event Argus HQ has on file for Becton, Dickinson and Company, BD Bio Sciences is dated 2025-08-13, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Becton, Dickinson and Company, BD Bio Sciences automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Becton, Dickinson and Company, BD Bio Sciences is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Becton, Dickinson and Company, BD Bio Sciences?

10 total: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 340335 →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytom… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Use… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FA… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 T… →
• Becton, Dickinson and Company, BD Bio Sciences — Class II recall: BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSD… →

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