# K023049: Synchron LX I 725 Clinical System

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 4, 2002 after 22 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011213 (2001). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011213: Modification to Synchron LX 20 Clinical Chemistry System, Beckman Coulter, Inc. (2001)

## Most influential descendants
- K060256: Unicel DXC 600I Synchron Access Clinical System (2006), 1 descendant of its own
- 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
- K042191: Diazyme Potassium Enzymatic Assay Kit (2004), 0 descendants of its own
- K042189: Diazyme Sodium Enzymatic Assay (2004), 0 descendants of its own

## Recalls of this device
- Feb 12, 2013 · Class II · Z-1034-2013: 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
- Apr 5, 2011 · Not classified · Z-2132-2011: The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.
- Oct 22, 2010 · Not classified · Z-2070-2011: This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.
- Oct 5, 2010 · Not classified · Z-1937-2011: 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 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.
- Jan 18, 2010 · Not classified · Z-2441-2010: 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
- Sep 11, 2008 · Not classified · Z-1374-2012: 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-2385-2008: 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-1096-2008: 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
- Mar 15, 2006 · Not classified · Z-0901-06: It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w
- Sep 6, 2005 · Not classified · Z-0009-06: Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the v
- Oct 10, 2003 · Not classified · Z-1098-04: Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.
- Oct 7, 2003 · Not classified · Z-1116-04: 'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
- Sep 18, 2003 · Not classified · Z-0096-04: Sample wheel may home to the wrong position.
- Jan 30, 2003 · Not classified · Z-0693-03: False results from secondary pour off tubes

## Indications for use
The SYNCHRON LXi 725 System combines the SYNCHRON LX20 PRO analyzer and the Access 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements. The SYNCHRON LX20 PRO 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 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/K023049
Methodology: https://510kreport.com/methodology