510(k) · Cleared
Recalled · Class II · 2025Cell-Dyn Ruby System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GKZ Counter, Differential Cell
Cleared on Jul 10, 2006 as substantially equivalent to K972354 (Abbott Laboratories, 1997) and 2 other predicates after a 26-day review. Its family tree reaches back 4 generations to 1982. It has been recalled 12 times.
- Decided
- Jul 10, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 12
- Predicates
- 3
Its longest line of descent runs back 4 generations to K823355 (1982). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
- 3 generations backK955715 Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer…Abbott Laboratories · 1996 · Recalled
- 2 generations backK972354 Abbott Cell-Dyn 3200 SystemAbbott Laboratories · 1997 · Recalled
- 1 generation backK980614 Abbott Cell-Dyn 3000 Series Hematology SystemsAbbott Laboratories · 1998 · Recalled
- This deviceK061667 Cell-Dyn Ruby SystemAbbott Laboratories · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K823355 | Coulter-Counter #S Plus IV & Lyse S +D | Coulter Electronics, Inc. | 1982 | — |
| −3 | K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) | Abbott Laboratories | 1996 | 1 |
| −2 | K972354 | Abbott Cell-Dyn 3200 System | Abbott Laboratories | 1997 | 6 |
| −1 | K980614 | Abbott Cell-Dyn 3000 Series Hematology Systems | Abbott Laboratories | 1998 | 5 |
| 0 (this device) | K061667 | Cell-Dyn Ruby System | Abbott Laboratories | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 2001 | 1 | 0 |
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 GKZ? 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 GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K972354 | Abbott Cell-Dyn 3200 SystemSummary page 1…ion Name: Automated Differential Cell Counter (21 CRF 864.5220) Predicate Device: CELL-DYN® 3200 System K972354 - September 16, 1997 K980614 - April 24, 1998 K012934 - September 28, 2001 I… | 1997 |
| * | K980614 | Abbott Cell-Dyn 3000 Series Hematology SystemsSummary page 1…(21 CRF 864.5220) Predicate Device: CELL-DYN® 3200 System K972354 - September 16, 1997 K980614 - April 24, 1998 K012934 - September 28, 2001 Intended Use: The CELL-DYN Ruby System is a m… | 1998 |
| * | K012934 | Cell-Dyn 3200 System with Absolute and Percent ReticulocyteSummary page 1…Device: CELL-DYN® 3200 System K972354 - September 16, 1997 K980614 - April 24, 1998 K012934 - September 28, 2001 Intended Use: The CELL-DYN Ruby System is a multiparameter, automated h… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2025 | Class II | Z-1655-2025 | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… |
| Mar 18, 2025 | Class II | Z-1653-2025 | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… |
| Mar 18, 2025 | Class II | Z-1654-2025 | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… |
| Mar 18, 2025 | Class II | Z-1656-2025 | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… |
| Mar 18, 2025 | Class II | Z-1652-2025 | Software change control | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… |
| Oct 19, 2023 | Class II | Z-0604-2024 | Under Investigation by firm | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). |
| Feb 13, 2017 | Class II | Z-1438-2017 | Nonconforming Material/Component | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage |
| Mar 15, 2011 | Not classified | Z-2019-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Apr 16, 2010 | Not classified | Z-2352-2010 | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. |
| Feb 12, 2009 | Not classified | Z-1398-2009 | Device Design | Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur. |
| Nov 17, 2008 | Not classified | Z-1064-2009 | Other | Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count. |
| Dec 22, 2006 | Not classified | Z-0565-2007 | Other | Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems. |
The 5 latest of 12 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 24 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 9 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K972354.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters: White Blood Cell Parameters WBC - White Blood Cell Concentration NEU - Neutrophil Absolute Concentration %N - Neutrophil Percentage of WBC LYM - Lymphocyte Absolute Concentration %L - Lymphocyte Percentage of WBC MONO - Monocyte Absolute Concentration %M - Monocyte Percentage of WBC EOS - Eosinophil Absolute Concentration %E -…
Read the full statement (140 words)
The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters:
White Blood Cell Parameters
WBC - White Blood Cell Concentration
NEU - Neutrophil Absolute Concentration
%N - Neutrophil Percentage of WBC
LYM - Lymphocyte Absolute Concentration
%L - Lymphocyte Percentage of WBC
MONO - Monocyte Absolute Concentration
%M - Monocyte Percentage of WBC
EOS - Eosinophil Absolute Concentration
%E - Eosinophil Percentage of WBC
BASO - Basophil Absolute Concentration
%B - Basophil Percentage of WBC
Red Blood Cell Parameters
RBC - Red Blood Cell Concentration
HCT - Hematocrit
MCV - Mean Cell Volume
RDW - Red Cell Distribution Width
%R - Reticulocyte Percent
RETC - Reticulocyte Absolute Concentration
Hemoglobin Parameters
HGB - Hemoglobin Concentration
MCH - Mean Cell Hemoglobin
MCHC - Mean Cell Hemoglobin Concentration
Platelet Parameters
PLT- Platelet Concentration
MPV- Mean Platelet Volume
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061667 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061667: Cell-Dyn Ruby System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061667
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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