# K011213: Modification to Synchron LX 20 Clinical Chemistry System

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: May 16, 2001 after 26 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042291: Unicel DXC 600 and 800 Synchron Systems (2004), 11 descendants of its own
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 5 descendants of its own
- K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own
- K191298: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own
- K023049: Synchron LX I 725 Clinical System (2002), 4 descendants of its own

## Recalls of this device
- Apr 5, 2011 · Not classified · Z-2131-2011: 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-2072-2011: 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.
- 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.
- Apr 5, 2007 · Not classified · Z-1095-2008: 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-0900-06: 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.
- Dec 16, 2002 · Not classified · Z-0545-03: The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

Source page: https://510kreport.com/device/K011213
Methodology: https://510kreport.com/methodology