510(k) · Cleared
Recalled · Class II · 2018Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · OYE Flow Cytometric Reagents And Accessories.
Cleared on Apr 10, 2015 as substantially equivalent to K961623 (Becton Dickinson Monoclonal Center, 1996) and 6 other predicates after a 268-day review. Its family tree reaches back 4 generations to 1996. 1 of the 21 devices in its family, counting itself, has a Class I recall. It has been recalled 6 times.
- Decided
- Apr 10, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- OYE
- Recalls
- 6
- Predicates
- 7
Its longest line of descent runs back 4 generations to K946055 (1996). 20 ancestors in all, the oldest K894651 (1989). No later device cites it as a predicate yet. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 3 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 2 generations backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- 1 generation backK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- This deviceK141932 Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel…Beckman Coulter, Inc. · 2015
Class I recalls in this family
- K140911 Unicel DXH 800 Coulter Cellular Analysis System/…direct predicate · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −3 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −2 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| −1 | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution | Becton Dickinson Immunocytometry Systems | 1998 | 1 |
| 0 (this device) | K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios… | Beckman Coulter, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 K232600 DxFLEX Flow Cytometer; ClearLLab 10C Panelsscore 6.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961623 | Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsSummary page 8…Classification 21 CFR Number Cleared Code CaliBRITE 3 Color and K961623 6/07/96 Class II 864.5220 GKZ FACSComp CaliBRITE APC beads CaliBRITE K973483 2/17/98 Class… | 1996 |
| * | K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetSummary page 8…Code CaliBRITE 3 Color and K961623 6/07/96 Class II 864.5220 GKZ FACSComp CaliBRITE APC beads CaliBRITE K973483 2/17/98 Class II 864.5220 GKZ 4 kit (unlabeled, FITC-, PE-, PerCP- and APC- labeled CaliBRITE beads), and FACSCom… | 1998 |
| * | K974360 | Multitest CD3/CD8/CD45/CD4Summary page 8…864.5220 GKZ 4 kit (unlabeled, FITC-, PE-, PerCP- and APC- labeled CaliBRITE beads), and FACSComp software (FACSCalibur) MultiTEST CD3/CD8/CD45/CD4 K974360 03/11/98 Class II 864.5220 GKZ Multitest K980858 5/22/98 Class II 8… | 1998 |
| * | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionSummary page 8…Comp software (FACSCalibur) MultiTEST CD3/CD8/CD45/CD4 K974360 03/11/98 Class II 864.5220 GKZ Multitest K980858 5/22/98 Class II 864.5220 GKZ CD3/CD16+56/CD45/CD19 Reagent and Multitest IMK Kit Lysing Solution with BD TruCoun… | 1998 |
| * | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter… Cleared while this submission was under review Summary page 8…8 Class II 864.5220 GKZ CD3/CD16+56/CD45/CD19 Reagent and Multitest IMK Kit Lysing Solution with BD TruCount Tubes Unicel DxH 800 K140911 09/05/14 Class II 864.5220 GKZ Immuno-Trol Control Cells K984216 03/16/99 Class II 8… | 2014 |
| * | K984216 | Immuno-Trol Control CellsSummary page 8…tion with BD TruCount Tubes Unicel DxH 800 K140911 09/05/14 Class II 864.5220 GKZ Immuno-Trol Control Cells K984216 03/16/99 Class II 864.8625 JPK Immuno-Trol Low Cells K013842 12/13/01 Class II 8… | 1999 |
| * | K013842 | Immuno-Trol Low CellsSummary page 8…lass II 864.5220 GKZ Immuno-Trol Control Cells K984216 03/16/99 Class II 864.8625 JPK Immuno-Trol Low Cells K013842 12/13/01 Class II 864.8625 JPK Device Description The AQUIOS CL Flow Cytometry System is composed of the follo… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2018 | Class II | Z-1341-2018 | Software design | The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification. |
| Oct 2, 2017 | Class II | Z-0091-2018 | Software design | The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS) |
| Aug 21, 2017 | Class II | Z-3135-2017 | Under Investigation by firm | Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect… |
| Apr 3, 2017 | Class II | Z-2035-2017 | Other | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. |
| Oct 19, 2016 | Class II | Z-0648-2017 | Under Investigation by firm | Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase… |
| Sep 6, 2016 | Class II | Z-2900-2016 | Software Design Change | Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K140911Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis…Beckman Coulter, Inc. · 2014 · Direct predicate · ◆ in the 2014 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K961623.
How does its category compare?
All OYE devicesOYE Flow Cytometric Reagents And Accessories.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OYE
1in 2023
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYE
40in 2025
MAUDE reports naming product code OYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 0 | — | 1 | 2 |
| 2017 | 2 | — | 1 | 9 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 10 | 6 |
| 2020 | 1 | — | 0 | 173 |
| 2021 | 0 | — | 0 | 251 |
| 2022 | 0 | — | 0 | 193 |
| 2023 | 1 | — | 0 | 141 |
| 2024 | 0 | — | 5 | 35 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral…
Read the full statement (495 words)
The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV). It is used in conjunction with the following reagents and software package.
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent
• Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
• CD45+ absolute count
• CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
• Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
• CD45+ absolute count
• CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling.
AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of;
- AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent
• Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts.
• CD45+ absolute count
• CD45+ Low SS (lymphocytes) percentage and absolute count
- AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent
• Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts.
• CD45+ absolute count
• CD45+ Low SS (lymphocytes) percentage and absolute count
AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.
AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141932: Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol Low, Aquios.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141932
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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