# K170974: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 3, 2017 after 91 days
- Product code: OYE (Flow Cytometric Reagents And Accessories.)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K946055 (1996). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141468: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration), Bd Biosciences (2015) Summary page 5.
- K062087: BD Facscanto II Flow Cytometer,  Model 338960; (5-3),  Model 339473; (4-2-2), Model 338962, Bd Biosciences (2006) Summary page 5.
- K040026: BD Facs 7-Color Setup Beads, Becton Dickinson Immunocytometry Systems (2004) Summary page 5.
- K090967: BD Multitest 6-Color TBNK Reagent, Model 644611, Bd Biosciences (2009) Summary page 5.
- K980858: Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution, Becton Dickinson Immunocytometry Systems (1998) Summary page 5.
- K974360: Multitest CD3/CD8/CD45/CD4, Becton Dickinson Immunocytometry Systems (1998) Summary page 5.
- K970836: Trucount Absolute Count Tubes/Counting Control Beads, Becton Dickinson Immunocytometry Systems (1997) Summary page 5.

## Cited in the summary but kept off the family tree
- K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC), R&D Systems, Inc. (1996). Our reading of the summary gave K961610, FDA’s number for R & D Systems' Whole Blood Flow Control, (R & D - WBFC) (R&D Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Multi-Check Control”. Kept off the family tree. Summary page 5.
- K982231: Statusflow, R&D Systems, Inc. (1998). Our reading of the summary gave K982231, FDA’s number for Statusflow (R&D Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Multi-Check CD4 Low Control”. Kept off the family tree. Summary page 5.

## Most influential descendants
- K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (2020), 0 descendants of its own

## Recalls of this device
- Nov 1, 2024 · Class II · Z-0745-2025: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S
- Nov 1, 2024 · Class II · Z-0748-2025: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S
- Nov 1, 2024 · Class II · Z-0749-2025: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S
- Nov 1, 2024 · Class II · Z-0746-2025: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S
- Nov 1, 2024 · Class II · Z-0747-2025: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S
- May 8, 2024 · Class II · Z-2351-2024: Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive ev
- Aug 19, 2019 · Class II · Z-0066-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0067-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0068-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0073-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0070-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0069-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0071-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0072-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Aug 19, 2019 · Class II · Z-0074-2020: Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio
- Jan 2, 2019 · Class III · Z-0792-2019: A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a relea
- May 16, 2018 · Class III · Z-2598-2018: The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

## Indications for use
The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+)

Source page: https://510kreport.com/device/K170974
Methodology: https://510kreport.com/methodology