Becton, Dickinson and Company, BD Biosciences

FDA Regulatory Profile

Summary

Total Recalls
35
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2351-2024Class IIBD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount TubesMay 8, 2024
Z-0641-2024Class IICD11b APC: ASR, REF: 340936, and CE, REF: 333143October 25, 2023
Z-0171-2023Class IIBD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BDOctober 3, 2022
Z-0172-2023Class IIBD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BDOctober 3, 2022
Z-0173-2023Class IIBD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyrOctober 3, 2022
Z-1215-2022Class IIBD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, whichMarch 25, 2022
Z-1214-2022Class IIBD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, whicMarch 25, 2022
Z-2333-2021Class IIBD" Mouse IgG2a Isotype Control APC X39 ASRJuly 22, 2021
Z-0562-2021Class IIBD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control fOctober 5, 2020
Z-1971-2020Class IIAnalyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 64139March 31, 2020
Z-0066-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount TubesAugust 19, 2019
Z-0073-2020Class IIBD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD TruAugust 19, 2019
Z-0074-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount TubesAugust 19, 2019
Z-0070-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount TubesAugust 19, 2019
Z-0071-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount TubesAugust 19, 2019
Z-0072-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount TubesAugust 19, 2019
Z-0068-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount TubesAugust 19, 2019
Z-0069-2020Class IIBD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD TrAugust 19, 2019
Z-0067-2020Class IIBD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount TubesAugust 19, 2019
Z-2358-2020Class IIBD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare hJuly 8, 2019