510(k) · Cleared
Recalled · Class II · 2013Synchron LX I 725 Clinical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Oct 4, 2002 as substantially equivalent to K011213 (Beckman Coulter, Inc., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it. It has been recalled 18 times.
- Decided
- Oct 4, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011213 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK011213 Modification to Synchron LX 20 Clinical Chemistry SystemBeckman Coulter, Inc. · 2001 · Recalled
- This deviceK023049 Synchron LX I 725 Clinical SystemBeckman Coulter, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK060256 Unicel DXC 600I Synchron Access Clinical SystemBeckman Coulter, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK103842 Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC…Beckman Coulter, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK042191 Diazyme Potassium Enzymatic Assay KitDiazyme Laboratories · 2004
- Descendant · cites it directly · 0 of its ownK042189 Diazyme Sodium Enzymatic AssayDiazyme Laboratories · 2004
Most influential descendants
Showing 4 of 4 · See all- K060256Unicel DXC 600I Synchron Access Clinical SystemBeckman Coulter, Inc. · 2006 · cites it directly1descendant
- K103842Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…Beckman Coulter, Inc. · 2011 · 2 generations on0descendants
- K042191Diazyme Potassium Enzymatic Assay KitDiazyme Laboratories · 2004 · cites it directly0descendants
- K042189Diazyme Sodium Enzymatic AssayDiazyme Laboratories · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | Beckman Coulter, Inc. | 2001 | 11 |
| 0 (this device) | K023049 | Synchron LX I 725 Clinical System | Beckman Coulter, Inc. | 2002 | — |
| +1 | K060256 | Unicel DXC 600I Synchron Access Clinical System | Beckman Coulter, Inc. | 2006 | 24 |
| +2 | K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800… | Beckman Coulter, Inc. | 2011 | 3 |
| +1 | K042191 | Diazyme Potassium Enzymatic Assay Kit | Diazyme Laboratories | 2004 | — |
| +1 | K042189 | Diazyme Sodium Enzymatic Assay | Diazyme Laboratories | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | 2001 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2013 | Class II | Z-1034-2013 | Device Design | 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 caused by the incubator belt pulley… |
| Nov 1, 2012 | Class II | Z-0612-2013 | Device Design | 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 may not turn at all, or may turn at… |
| Apr 5, 2011 | Not classified | Z-2132-2011 | Equipment maintenance | 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 | Environmental control | 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 | Pending | 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 degrade, become brittle and… |
| Aug 10, 2010 | Not classified | Z-1619-2011 | Other | 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 drawn by lancets are more likely to be… |
| Apr 15, 2010 | Not classified | Z-2388-2010 | Other | 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 | Other | 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 result in dilution of the sample with… |
| Sep 11, 2008 | Not classified | Z-1374-2012 | Software design | 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 | 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 17, 2007 | Not classified | Z-1183-2008 | Process control | 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 soldering. |
| Apr 5, 2007 | Not classified | Z-1096-2008 | Software design | 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. -Stirrer motors can stall without any flags… |
| Mar 15, 2006 | Not classified | Z-0901-06 | Other | 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/operating software version 4.5.… |
| Sep 6, 2005 | Not classified | Z-0009-06 | Software design | 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 volume of 24 hour urine sample, results… |
| Oct 10, 2003 | Not classified | Z-1098-04 | Other | 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 | Other | '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 | Other | Sample wheel may home to the wrong position. |
| Jan 30, 2003 | Not classified | Z-0693-03 | Other | False results from secondary pour off tubes |
The 5 latest of 18 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 JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (171 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023049: Synchron LX I 725 Clinical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023049
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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