# K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 10, 1997 after 70 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883181 (1988). 3 ancestors in all.
17 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)
- K950958: Synchon CX Delta Clin Syst (CX4, CX5, CX7 Delta), Beckman Instruments, Inc. (1995) Summary page 2.
- K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage, Beckman Instruments, Inc. (1988) Summary page 2.
- K942676: Synchron CX3 Delta, Beckman-Diagnostic Systems Group (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- K850958: Blood Gas Sampler Kit, Churchill Corp. (1985). Our OCR of the scanned summary read K850958, FDA’s number for Blood Gas Sampler Kit (Churchill Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SYNCHRON Systems Creatinine”. Kept off the family tree. Summary page 2.
- K952676: Branemark System Ball Attachment System, Nobelpharma USA, Inc. (1995). Our OCR of the scanned summary read K952676, FDA’s number for Branemark System Ball Attachment System (Nobelpharma USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SYNCHRON Systems Protein Cal”. Kept off the family tree. Summary page 2.

## 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
- K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2021), 3 descendants of its own

## Recalls of this device
- Apr 5, 2011 · Not classified · Z-2130-2011: 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-2071-2011: 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.
- Sep 22, 2010 · Class II · Z-1951-2013: Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on
- 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
- Aug 2, 2010 · Not classified · Z-2389-2010: The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in mod
- 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-1094-2008: 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
- 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.

## Indications for use
The SYNCHRON LX20 Clinical Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro quantitative measurement 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/K965240
Methodology: https://510kreport.com/methodology