# K042291: Unicel DXC 600 and 800 Synchron Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 12, 2004 after 80 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 34 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883181 (1988). 5 ancestors in all.
11 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L, Beckman Instruments, Inc. (1997) Summary page 1.
- K011213: Modification to Synchron LX 20 Clinical Chemistry System, Beckman Coulter, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K223755: i-STAT G cartridge with the i-STAT 1 System (2023), 1 descendant of its own

## Recalls of this device
- Jan 29, 2020 · Class II · Z-2136-2020: Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in th
- Dec 5, 2018 · Class II · Z-1078-2019: When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during
- Aug 21, 2014 · Class II · Z-2687-2014: Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassa
- May 14, 2014 · Class II · Z-1737-2014: Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
- Apr 22, 2014 · Class II · Z-2272-2016: Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron Systems.
- Sep 3, 2012 · Class II · Z-0123-2013: Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle t
- Jul 6, 2012 · Class II · Z-0059-2013: The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with UniCel Closted Tube Aliquotter (UCTA) serial
- Oct 13, 2011 · Class II · Z-2257-2012: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
- Oct 13, 2011 · Class II · Z-2259-2012: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
- Oct 13, 2011 · Class II · Z-2258-2012: The recall was initiated because Beckman Coulter has received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
- Aug 1, 2011 · Class II · Z-0347-2013: The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
- Jan 26, 2011 · Not classified · Z-1938-2011: The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation ar
- Jan 26, 2011 · Not classified · Z-1940-2011: The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation ar
- Jan 26, 2011 · Not classified · Z-1939-2011: The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation ar
- Nov 16, 2010 · Not classified · Z-1972-2011: The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator cou
- Oct 22, 2010 · Not classified · Z-2075-2011: 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 22, 2010 · Not classified · Z-2077-2011: 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 22, 2010 · Not classified · Z-2076-2011: 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 22, 2010 · Not classified · Z-2078-2011: 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 22, 2010 · Not classified · Z-2080-2011: 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 22, 2010 · Not classified · Z-2081-2011: 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 22, 2010 · Not classified · Z-2074-2011: 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 22, 2010 · Not classified · Z-2079-2011: 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 22, 2010 · Not classified · Z-2073-2011: 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
- Jul 6, 2010 · Not classified · Z-2686-2011: Test results may have incorrect ranges. If a default sample type setting on the tests screen is changed while running Unicel DXI system software version 4.3, the new setting is not saved to the system
- 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 4, 2010 · Not classified · Z-0863-2010: Excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results.
- Jul 23, 2009 · Not classified · Z-2633-2011: The recall was initiated because the Wash Concentrate Tube Assembly 142 may fail to deliver the appropriate amount of wash concentrate on some SYNCHRON DxC Systems due to an accumulation of crystals. 
- Apr 5, 2007 · Not classified · Z-1099-2008: 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
- Apr 5, 2007 · Not classified · Z-1101-2008: 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
- Apr 5, 2007 · Not classified · Z-1100-2008: 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
- Apr 5, 2007 · Not classified · Z-1097-2008: 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-0902-06: 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

## Indications for use
The UniCel DxC SYNCHRON Systems are fully automated, computer-controlled clinical chemistry analyzers 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).

Source page: https://510kreport.com/device/K042291
Methodology: https://510kreport.com/methodology