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Becton, Dickinson and Company, BD Bio Sciences

FDA Regulatory Profile

Summary

Total Recalls
10
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2238-2025Class IIBD Trucount Controls, 30 Test - REF: 340335July 8, 2025
Z-2237-2025Class IIBD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDJuly 8, 2025
Z-2078-2025Class IIREF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry June 3, 2025
Z-2079-2025Class IIREF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescencJune 3, 2025
Z-0749-2025Class IIFACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181November 1, 2024
Z-0748-2025Class IIFACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearancNovember 1, 2024
Z-0747-2025Class IIFACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearanceNovember 1, 2024
Z-0746-2025Class IIDevice Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 ThNovember 1, 2024
Z-0745-2025Class IIFACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytomeNovember 1, 2024
Z-0009-2025Class IIBD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample PreparatiAugust 12, 2024