FDA recall record · openFDA

Becton, Dickinson and Company, BD Bio Sciences

10 FDA recalls on record (2024–2025) — 10 device. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of t 5

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup 2

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the a 2

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume d 1

Recalls

REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation. Class II 2025-06-03 BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD Class II 2025-07-08 BD Trucount Controls, 30 Test - REF: 340335 Class II 2025-07-08 REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence com Class II 2025-06-03 BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), RE Class II 2024-08-12 FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for Class II 2024-11-01 FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 Class II 2024-11-01 FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes Class II 2024-11-01 FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes Class II 2024-11-01 Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance Class II 2024-11-01

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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