← Every firm
Becton, Dickinson and Company, BD Bio Sciences FDA Recalls
10 recalls on file across devices, 0 of them Class I and 10 still open. Matched by name to BDX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDClass IIJul 8, 2025Control kits contain incorrect standard deviation (SD) value |
| BD Trucount Controls, 30 Test - REF: 340335Class IIJul 8, 2025Control kits contain incorrect standard deviation (SD) value |
| REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.Class IIJun 3, 2025Due to customer complaints, errors in spectral overlap facto |
| REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence comClass IIJun 3, 2025Due to customer complaints, errors in spectral overlap facto |
| FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for Class IINov 1, 2024On October 18, 2024, BD has identified through customer comp |
| FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes Class IINov 1, 2024On October 18, 2024, BD has identified through customer comp |
| FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describesClass IINov 1, 2024On October 18, 2024, BD has identified through customer comp |
| FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181Class IINov 1, 2024On October 18, 2024, BD has identified through customer comp |
| Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance Class IINov 1, 2024On October 18, 2024, BD has identified through customer comp |
| BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REClass IIAug 12, 2024Sample preparation system with software may cause: 1) Multid |