510(k) · Cleared
Recalled · 2011Modification to Synchron LX 20 Clinical Chemistry 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 May 16, 2001 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled 11 times.
- Decided
- May 16, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- JGS
- Recalls
- 11
- Predicates
- 0
20 later devices descend from it, 5 citing it directly.
- This deviceK011213 Modification to Synchron LX 20 Clinical Chemistry SystemBeckman Coulter, Inc. · 2001
- Descendant · cites it directly · 11 of its ownK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 5 of its ownK183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK191298 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK023049 Synchron LX I 725 Clinical SystemBeckman Coulter, Inc. · 2002 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K042291Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · cites it directly11descendants
- K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on5descendants
- K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on4descendants
- K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on4descendants
- K023049Synchron LX I 725 Clinical SystemBeckman Coulter, Inc. · 2002 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | Beckman Coulter, Inc. | 2001 | — |
| +1 | K042291 | Unicel DXC 600 and 800 Synchron Systems | Beckman Coulter, Inc. | 2004 | 34 |
| +2 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +1 | K023049 | Synchron LX I 725 Clinical System | Beckman Coulter, Inc. | 2002 | 18 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042291 | Unicel DXC 600 and 800 Synchron Systems | 2004 | 11 |
| K023049 | Synchron LX I 725 Clinical System | 2002 | 4 |
| K014034 | Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro) | 2001 | 1 |
| K051108 | Piccolo Lactate Dephydrogenase Test System | 2005 | 0 |
| K040174 | Bilirubin Assay on the Omni S Analyzer | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2011 | Not classified | Z-2131-2011 | 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-2072-2011 | 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. |
| 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. |
| Apr 5, 2007 | Not classified | Z-1095-2008 | 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-0900-06 | 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. |
| Dec 16, 2002 | Not classified | Z-0545-03 | Other | The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042291 (Beckman Coulter, Inc., 2004) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K011213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011213: Modification to Synchron LX 20 Clinical Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011213
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026