510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

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

K170974510(k) TraditionalCleared Jul 3, 201791-day reviewClass II21 CFR 864.5220Recalls 17

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson and Company · OYE Flow Cytometric Reagents And Accessories.

Cleared on Jul 3, 2017 as substantially equivalent to K141468 (Bd Biosciences, 2015) and 6 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it. It has been recalled 17 times.

Decided
Jul 3, 2017
Review
91 days
Class
Class II
Product code
OYE
Recalls
17
Predicates
9

Its longest line of descent runs back 6 generations to K946055 (1996). 23 ancestors in all, the oldest K913192 (1992). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2006: 1 other ancestor2004: 3 other ancestors1997: 5 other ancestors2000: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor2020: 1 descendant clearedK946055 · Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp · Becton Dickinson Immunocytometry Systems · 1996 · recalledK963963 · Multiset Software for Automated Flow Cytometric Data Analysis · Becton Dickinson Immunocytometry Systems · 1996 · recalled×2: 2 generations cleared close together, K974360 (1998), K980858 (1998) K060375 · BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 · Bd Biosciences · 2006K090967 · BD Multitest 6-Color TBNK Reagent, Model 644611 · Bd Biosciences · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 12 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K090967 · BD Multitest 6-Color TBNK Reagent, Model 644611 · Bd Biosciences · 2009 · recalledK060375 · BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 · Bd Biosciences · 2006K980858 · Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution · Becton Dickinson Immunocytometry Systems · 1998 · recalledK974360 · Multitest CD3/CD8/CD45/CD4 · Becton Dickinson Immunocytometry Systems · 1998K963963 · Multiset Software for Automated Flow Cytometric Data Analysis · Becton Dickinson Immunocytometry Systems · 1996 · recalledK946055 · Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp · Becton Dickinson Immunocytometry Systems · 1996 · recalled−50
  1. Root · 6 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
  2. 5 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
  3. 4 generations backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
  4. 3 generations backK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
  5. 2 generations backK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
  6. 1 generation backK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
  7. This deviceK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017
  8. Descendant · cites it directly · 0 of its ownK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K946055Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems19961
−5K963963Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems19961
−4K974360Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems1998—
−3K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems19981
−2K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences2006—
−1K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences20093
0 (this device)K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company2017—
+1K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical…Becton, Dickinson and Company20205

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199420
199620
199750
199810
200010
200430
200610
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K170974, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OYE device

  1. #1 K232600 DxFLEX Flow Cytometer; ClearLLab 10C Panelsscore 6.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…
Summary page 5
…CSCanto™ II system with BD Multitest™ reagents that consists of the following:  FACSCanto II flow cytometer (4-2, 4-2-2 and 5-3 optical configurations) (K141468 and K062087)  FACSCanto Clinical Software (Multitest 6-Color and 4-Color assays are included as pa…
Bd Biosciences2015—
*K062087BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962
Summary page 5
…BD Multitest™ reagents that consists of the following:  FACSCanto II flow cytometer (4-2, 4-2-2 and 5-3 optical configurations) (K141468 and K062087)  FACSCanto Clinical Software (Multitest 6-Color and 4-Color assays are included as panels within FACSCanto C…
Bd Biosciences20063
*K040026BD Facs 7-Color Setup Beads
Summary page 5
…are (Multitest 6-Color and 4-Color assays are included as panels within FACSCanto Clinical software) (K141468 and K062087)  FACS 7-Color Setup Beads (K040026)  Multitest 6-Color TBNK (K090967)  Multitest IMK Kit (K980858)  Multitest CD3/CD8/CD45/CD4 (K974360)…
Becton Dickinson Immunocytometry Systems20043
*K090967BD Multitest 6-Color TBNK Reagent, Model 644611
Summary page 5
…re included as panels within FACSCanto Clinical software) (K141468 and K062087)  FACS 7-Color Setup Beads (K040026)  Multitest 6-Color TBNK (K090967)  Multitest IMK Kit (K980858)  Multitest CD3/CD8/CD45/CD4 (K974360)  Multitest CD3/C16+CD56/CD45/CD19…
Bd Biosciences20093
*K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution
Summary page 5
…n FACSCanto Clinical software) (K141468 and K062087)  FACS 7-Color Setup Beads (K040026)  Multitest 6-Color TBNK (K090967)  Multitest IMK Kit (K980858)  Multitest CD3/CD8/CD45/CD4 (K974360)  Multitest CD3/C16+CD56/CD45/CD19 (K980858)  Multi-Check Contro…
Becton Dickinson Immunocytometry Systems19981
*K974360Multitest CD3/CD8/CD45/CD4
Summary page 5
…2087)  FACS 7-Color Setup Beads (K040026)  Multitest 6-Color TBNK (K090967)  Multitest IMK Kit (K980858)  Multitest CD3/CD8/CD45/CD4 (K974360)  Multitest CD3/C16+CD56/CD45/CD19 (K980858)  Multi-Check Control (K961610)  Multi-Check CD4 Low Contr…
Becton Dickinson Immunocytometry Systems1998—
Kept off the family treeK961610FDA’s K961610 is R & D Systems' Whole Blood Flow Control, (R & D - WBFC)
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
… Multitest IMK Kit (K980858)  Multitest CD3/CD8/CD45/CD4 (K974360)  Multitest CD3/C16+CD56/CD45/CD19 (K980858)  Multi-Check Control (K961610)  Multi-Check CD4 Low Control (K982231)  Trucount Tubes (K970836)  Optional FACS Loader (K141468 and K…
R&D Systems, Inc.1996—
Kept off the family treeK982231FDA’s K982231 is Statusflow
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
…Multitest CD3/CD8/CD45/CD4 (K974360)  Multitest CD3/C16+CD56/CD45/CD19 (K980858)  Multi-Check Control (K961610)  Multi-Check CD4 Low Control (K982231)  Trucount Tubes (K970836)  Optional FACS Loader (K141468 and K062087) BD Biosciences Premarket Notification…
R&D Systems, Inc.19981
*K970836Trucount Absolute Count Tubes/Counting Control Beads
Summary page 5
…0)  Multitest CD3/C16+CD56/CD45/CD19 (K980858)  Multi-Check Control (K961610)  Multi-Check CD4 Low Control (K982231)  Trucount Tubes (K970836)  Optional FACS Loader (K141468 and K062087) BD Biosciences Premarket Notification…
Becton Dickinson Immunocytometry Systems19972

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company20200

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 1, 2024Class IIZ-0745-2025Nonconforming Material/ComponentOn 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 M3S4S6) on BD FACSLyric flow cytometers…
Nov 1, 2024Class IIZ-0748-2025Nonconforming Material/ComponentOn 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 M3S4S6) on BD FACSLyric flow cytometers…
Nov 1, 2024Class IIZ-0749-2025Nonconforming Material/ComponentOn 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 M3S4S6) on BD FACSLyric flow cytometers…
Nov 1, 2024Class IIZ-0746-2025Nonconforming Material/ComponentOn 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 M3S4S6) on BD FACSLyric flow cytometers…
Nov 1, 2024Class IIZ-0747-2025Nonconforming Material/ComponentOn 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 M3S4S6) on BD FACSLyric flow cytometers…
May 8, 2024Class IIZ-2351-2024Material/Component ContaminationMultitest 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 event increase on CD3+CD4+vsCD3+CD8+…
Aug 19, 2019Class IIZ-0066-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0067-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0068-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0073-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0070-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0069-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0071-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0072-2020Under Investigation by firmFlow 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 of cell population events to bead…
Aug 19, 2019Class IIZ-0074-2020Under Investigation by firmFlow 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 of cell population events to bead…
Jan 2, 2019Class IIIZ-0792-2019Under Investigation by firmA 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 released configuration for clinical use. It…
May 16, 2018Class IIIZ-2598-2018Nonconforming Material/ComponentThe solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.

The 5 latest of 17 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • 11 of the 23 ancestors have a recall of any class.
  • Of its descendants, K201814 (Becton, Dickinson and Company, 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OYE devices

OYE Flow Cytometric Reagents And Accessories.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · OYE

1in 2023

2013: 22015: 22017: 22020: 12023: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OYE

Too few OYE 510(k)s in any year since 2007 to give a median.

Recalls per year · OYE

1in 2025

2016: 12017: 12019: 102024: 52025: 1
2007high 10 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OYE

40in 2025

2013: 42014: 92015: 62016: 22017: 92018: 252019: 62020: 1732021: 2512022: 1932023: 1412024: 352025: 40
2007high 251 (2021) · low 0 (2007)2025

MAUDE reports naming product code OYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20132—04
20140—09
20152—06
20160—12
20172—19
20180—025
20190—106
20201—0173
20210—0251
20220—0193
20231—0141
20240—535
20250—140
20261—0—

What is it indicated for?

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™…

Read the full statement (249 words)

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+)

Indications for use as stated in the FDA summary.

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164 FDA decisions under this applicant name. See the company

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  • K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026
  • K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with…Becton, Dickinson and Company · 2026

Recent decisions in OYE

The OYE category page

  • K260215BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3]…Bd Biosciences · 2026
  • K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 20231 recall
  • K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample…Becton, Dickinson and Company · 20205 recalls
  • K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow…Beckman Coulter · 2017
  • K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol…Beckman Coulter, Inc. · 20156 recalls

https://510kreport.com/device/K170974 · printed Nov 5, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170974

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026