510(k) · Cleared
Recalled · Class II · 2025Unicel Dxi 800 Access Immunoassay System, Model 973100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jan 28, 2003 as substantially equivalent to K922823 (Bio-Rad Laboratories, Inc., 1992) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it. It has been recalled 31 times.
- Decided
- Jan 28, 2003
- Review
- 77 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 31
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922823 (1992). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK922823 Access Theophylline Immunoassay ReagentsBio-Rad Laboratories, Inc. · 1992 · Recalled
- This deviceK023764 Unicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK190298 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access…Beckman Coulter Biomedical GmbH · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK192064 LIAISON Vitamin B12DiaSorin, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · cites it directly4descendants
- K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 2 generations on3descendants
- K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 3 generations on1descendant
- K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH · 2019 · cites it directly0descendants
- K192064LIAISON Vitamin B12DiaSorin, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922823 | Access Theophylline Immunoassay Reagents | Bio-Rad Laboratories, Inc. | 1992 | 19 |
| 0 (this device) | K023764 | Unicel Dxi 800 Access Immunoassay System, Model 973100 | Beckman Coulter, Inc. | 2003 | — |
| +1 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| +2 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| +3 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access… | Beckman Coulter, Inc. | 2014 | 4 |
| +1 | K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate… | Beckman Coulter Biomedical GmbH | 2019 | 4 |
| +4 | K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 2 | 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 JJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K922823 | Access Theophylline Immunoassay ReagentsSummary page 1…hemistry analyzer for clinical use Legally Marketed (Predicate) Access@2 Immunoassay System, Manufactured by Device Beckman Coulter, Inc., (K922823 “Add to File” Letter, dated May 18,2001 and PMA Supplement P980… | 1992 |
| * | P980041 | Access Afp Immunoassay SystemSummary page 1…Beckman Coulter, Inc., (K922823 “Add to File” Letter, dated May 18,2001 and PMA Supplement P980041/S001, cleared October 1,2002) Device Description The UniCel Dxl 800 Access Immunoassay System is a floor model, microcomputer c… | 1999 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090588 | Power Processor Sample Processing System with Generic Connection Module, Model: 4210 | 2009 | 4 |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH… | 2019 | 0 |
| K121790 | Access Accutni Reagent, Access Accutni Calibrator, Unicel Dxi 800 Access Immunoassay… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2025 | Class II | Z-2268-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 25, 2025 | Class II | Z-2267-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 25, 2025 | Class II | Z-2269-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 25, 2025 | Class II | Z-2266-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 25, 2025 | Class II | Z-2271-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 25, 2025 | Class II | Z-2270-2025 | Device Design | Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A… |
| Jun 20, 2023 | Class II | Z-2237-2023 | Under Investigation by firm | Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used… |
| Dec 5, 2018 | Class II | Z-1077-2019 | Under Investigation by firm | When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead… |
| Sep 18, 2018 | Class II | Z-2763-2019 | Process design | Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%). |
| Aug 21, 2014 | Class II | Z-2687-2014 | Under Investigation by firm | Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and… |
| Nov 26, 2013 | Class II | Z-0985-2014 | Nonconforming Material/Component | The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. |
| Oct 13, 2011 | Class II | Z-2257-2012 | Software design | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. |
| Oct 13, 2011 | Class II | Z-2259-2012 | Software design | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. |
| Oct 13, 2011 | Class II | Z-2258-2012 | Software design | The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results. |
| Aug 1, 2011 | Class II | Z-0345-2013 | Process design | The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. |
| Aug 1, 2011 | Class II | Z-0346-2013 | Process design | The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies. |
| Apr 15, 2011 | Not classified | Z-3127-2011 | Other | The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4… |
| Jan 26, 2011 | Not classified | Z-1938-2011 | Pending | The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the… |
| Jan 26, 2011 | Not classified | Z-1940-2011 | Pending | The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the… |
| Jan 26, 2011 | Not classified | Z-1939-2011 | Pending | The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the… |
| Aug 13, 2010 | Not classified | Z-0607-2011 | Pending | This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of… |
| Jul 6, 2010 | Not classified | Z-2685-2011 | Software design | Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system database. The changed sample type… |
| Oct 28, 2009 | Not classified | Z-0856-2010 | Software design | This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and… |
| Oct 9, 2008 | Not classified | Z-0914-2010 | Other | The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is… |
| Apr 3, 2008 | Not classified | Z-2387-2008 | Nonconforming Material/Component | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. |
| Oct 8, 2007 | Not classified | Z-1184-2008 | Device Design | Incorrect results: There is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay… |
| Jul 19, 2007 | Not classified | Z-1108-2008 | Process design | Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. |
| Jul 28, 2006 | Not classified | Z-1518-06 | Other | The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty.… |
| Feb 6, 2006 | Not classified | Z-0583-06 | Software design | The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances) |
| Oct 29, 2004 | Not classified | Z-0371-05 | Other | Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a… |
| Mar 29, 2004 | Not classified | Z-0904-04 | Other | Software coding error may cause a fatal error message. |
The 5 latest of 31 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
The UniCel Dxl 800 Access Immunoassay System is a microcomputercontrolled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator lo interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or…
Read the full statement (417 words)
The UniCel Dxl 800 Access Immunoassay System is a microcomputercontrolled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (UI) software and allows the operator lo interface with and direct the instrument software. The UniCel Dxl 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrationsfound in human body fluids. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access AccuTnl assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage.
Cardiac troponin I determination aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
The Access@Cortisol Assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum, using the Access Immunoassay Systems.
Levels of estradiol are useful in monitoring ovulatory status. Because Estradiol levels reflect follicular maturation, the measurement of estradiol is a valuable tool in the assessment of sexual development, etiology of amenorrhea, causes of infertility and menopause. Abnormally high levels in males are indicative of feminizing syndromes such as gynecomastia.
The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
The Access HYPERsensitive hTSH assay proviws in vitro quanl tative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023764
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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