# K060256: Unicel DXC 600I Synchron Access Clinical System

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 27, 2006 after 26 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011213 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023049: Synchron LX I 725 Clinical System, Beckman Coulter, Inc. (2002) Summary page 1.

## Most influential descendants
- K103842: Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System Software Version 5.0 (2011), 0 descendants of its own

## Recalls of this device
- Jan 26, 2023 · Class II · Z-1257-2023: An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/
- Nov 6, 2017 · Class III · Z-0310-2018: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
- Oct 6, 2014 · Class II · Z-0176-2015: Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the anal
- Apr 22, 2014 · Class II · Z-2272-2016: Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
- Feb 12, 2013 · Class II · Z-1035-2013: Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caus
- Nov 1, 2012 · Class II · Z-0612-2013: It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley
- Sep 3, 2012 · Class II · Z-0123-2013: Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle t
- Jul 6, 2012 · Class II · Z-0059-2013: The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial
- Nov 16, 2010 · Not classified · Z-1972-2011: The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator cou
- Oct 5, 2010 · Not classified · Z-1936-2011: The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can 
- 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 
- Aug 10, 2010 · Not classified · Z-1619-2011: The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples draw
- Apr 15, 2010 · Not classified · Z-2388-2010: UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
- Feb 25, 2010 · Not classified · Z-2590-2010: Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Moto
- Jan 18, 2010 · Not classified · Z-2442-2010: The recall was initiated due to " A loose Aliquot Probe tube fitting in the Closed Tube Aliquotter (CTA), may result in erroneous Access immunoassay results or Synchron chemistry results". This may re
- Jan 4, 2010 · Not classified · Z-0863-2010: Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
- 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 
- Jul 23, 2009 · Not classified · Z-2633-2011: The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. 
- May 7, 2009 · Not classified · Z-2771-2011: The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstatio
- 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
- Sep 11, 2008 · Not classified · Z-1375-2012: The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
- Apr 3, 2008 · Not classified · Z-2386-2008: 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 17, 2007 · Not classified · Z-1183-2008: Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate s
- Apr 5, 2007 · Not classified · Z-1098-2008: Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirr

## Indications for use
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements. The UniCel DxC 600 Synchron® Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent). The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic in particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).

Source page: https://510kreport.com/device/K060256
Methodology: https://510kreport.com/methodology