# K023764: Unicel Dxi 800 Access Immunoassay System, Model 973100

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 28, 2003 after 77 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922823 (1992). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922823: Access Theophylline Immunoassay Reagents, Bio-Rad Laboratories, Inc. (1992) Summary page 1.
- P980041: Access Afp Immunoassay System, Beckman Coulter, Inc. (1999) Summary page 1.

## Most influential descendants
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own
- K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (2019), 0 descendants of its own
- K192064: LIAISON Vitamin B12 (2019), 0 descendants of its own

## Recalls of this device
- Jun 25, 2025 · Class II · Z-2268-2025: 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-moto
- Jun 25, 2025 · Class II · Z-2267-2025: 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-moto
- Jun 25, 2025 · Class II · Z-2269-2025: 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-moto
- Jun 25, 2025 · Class II · Z-2266-2025: 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-moto
- Jun 25, 2025 · Class II · Z-2271-2025: 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-moto
- Jun 25, 2025 · Class II · Z-2270-2025: 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-moto
- Jun 20, 2023 · Class II · Z-2237-2023: 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
- Dec 5, 2018 · Class II · Z-1077-2019: 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
- Sep 18, 2018 · Class II · Z-2763-2019: 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: 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 Immunoassa
- Nov 26, 2013 · Class II · Z-0985-2014: 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 incorrec
- Oct 13, 2011 · Class II · Z-2257-2012: 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: 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: 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: 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: 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: 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
- Jan 26, 2011 · Not classified · Z-1938-2011: 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 ar
- Jan 26, 2011 · Not classified · Z-1940-2011: 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 ar
- Jan 26, 2011 · Not classified · Z-1939-2011: 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 ar
- Aug 13, 2010 · Not classified · Z-0607-2011: 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 
- Jul 6, 2010 · Not classified · Z-2685-2011: 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
- Oct 28, 2009 · Not classified · Z-0856-2010: 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 
- Oct 9, 2008 · Not classified · Z-0914-2010: 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 negati
- Apr 3, 2008 · Not classified · Z-2387-2008: 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
- Oct 8, 2007 · Not classified · Z-1184-2008: 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 th
- Jul 19, 2007 · Not classified · Z-1108-2008: 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: 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 
- Feb 6, 2006 · Not classified · Z-0583-06: 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: 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. Deforme
- Mar 29, 2004 · Not classified · Z-0904-04: Software coding error may cause a fatal error message.

## Indications for use
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.

Source page: https://510kreport.com/device/K023764
Methodology: https://510kreport.com/methodology