Flow Cytometric Reagents And Accessories.
FDA product code OYE · Class II (moderate risk) · 21 CFR 864.5220 · Hematology
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
8510(k) clearances
0PMA approvals
26recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C PanelsOYE · Traditional | Beckman Coulter, Inc. | 11/22/2023SE |
| K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…OYE · Traditional | Becton, Dickinson and Company | 09/28/2020SE |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…OYE · Traditional | Becton, Dickinson and Company | 07/03/2017SE |
| K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…OYE · Traditional | Beckman Coulter | 06/23/2017SE |
| K141932 | Aquios CL Flow Cytometer, Aquios TETRA-1 Panel,Aquios TETRA-2+PANEL, Aquios Immuno-Trol…OYE · Traditional | Beckman Coulter, Inc. | 04/10/2015SE |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…OYE · Traditional | Bd Biosciences | 02/27/2015SE |
| K130373 | Navios Flow Cytometer SystemOYE · Traditional | Beckman Coulter, Inc. | 09/18/2013SE |
| K121445 | Tetrachrome Reagents and Tetracxp SystemOYE · Special | Beckman Coulter, Inc. | 07/26/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0541-2026 Class II | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow…Due to a software error code that crashes during acquisition on patient sample when running customer defined… | Beckman Coulter Inc. | 09/22/2025Open, Classified |
| Z-0749-2025 Class II | FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181On October 18, 2024, BD has identified through customer complaints and an increase in field failures /… | Becton, Dickinson and Company, BD Bio… | 11/01/2024Open, Classified |
| Z-0748-2025 Class II | FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974…On October 18, 2024, BD has identified through customer complaints and an increase in field failures /… | Becton, Dickinson and Company, BD Bio… | 11/01/2024Open, Classified |
| Z-0747-2025 Class II | FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974…On October 18, 2024, BD has identified through customer complaints and an increase in field failures /… | Becton, Dickinson and Company, BD Bio… | 11/01/2024Open, Classified |
| Z-0746-2025 Class II | Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI…On October 18, 2024, BD has identified through customer complaints and an increase in field failures /… | Becton, Dickinson and Company, BD Bio… | 11/01/2024Open, Classified |
| Z-0745-2025 Class II | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric"…On October 18, 2024, BD has identified through customer complaints and an increase in field failures /… | Becton, Dickinson and Company, BD Bio… | 11/01/2024Open, Classified |
| Z-2351-2024 Class II | BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD…Multitest with compromised raw material used to assess immune system status may result in flow cytometry… | Becton, Dickinson and Company, BD Biosciences | 05/08/2024Open, Classified |
| Z-0074-2020 Class II | BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0073-2020 Class II | BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0072-2020 Class II | BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0071-2020 Class II | BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0070-2020 Class II | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0069-2020 Class II | BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0068-2020 Class II | BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0067-2020 Class II | BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0066-2020 Class II | BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD…Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic… | Becton, Dickinson and Company, BD Biosciences | 08/19/2019Terminated |
| Z-0792-2019 Class III | BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD…A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed… | Becton, Dickinson and Company, BD Biosciences | 01/02/2019Terminated |
| Z-2598-2018 Class III | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879…The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader… | Becton, Dickinson and Company, BD Biosciences | 05/16/2018Terminated |
| Z-1341-2018 Class II | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is…The device may process the same sample with two different sample IDs and sample information while using the… | Beckman Coulter Inc. | 01/29/2018Terminated |
| Z-0091-2018 Class II | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman…The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory… | Beckman Coulter Inc. | 10/02/2017Terminated |
| Z-3135-2017 Class II | AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an…Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can… | Beckman Coulter Inc. | 08/21/2017Terminated |
| Z-2035-2017 Class II | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage:…Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System… | Beckman Coulter Inc. | 04/03/2017Terminated |
| Z-0648-2017 Class II | AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is…Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of… | Beckman Coulter Inc. | 10/19/2016Terminated |
| Z-2900-2016 Class II | AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic…Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to… | Beckman Coulter Inc. | 09/06/2016Terminated |
| Z-1370-2015 Class II | BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps… | BD Biosciences, Systems & Reagents | 03/06/2015Terminated |
| Z-1977-2014 Class II | BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In…Laser cooling fans and internal fan of the associated fluidics cart are not operational. | BD Biosciences, Systems & Reagents | 06/06/2014Terminated |