510(k) · Cleared
Recalled · Class II · 2020Unicel DXC 600 and 800 Synchron Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CEM Electrode, Ion Specific, Potassium
Cleared on Nov 12, 2004 as substantially equivalent to K965240 (Beckman Instruments, Inc., 1997) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1988. 11 later devices descend from it. It has been recalled 34 times.
- Decided
- Nov 12, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 34
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883181 (1988). 5 ancestors in all. 11 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 1 generation backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- This deviceK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK191298 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK223755 i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
2006high 3 (2020) · low 0 (2008)2026
Most influential descendants
Showing 5 of 11 · See all- K183688i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · cites it directly5descendants
- K183678i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · cites it directly4descendants
- K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · cites it directly4descendants
- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021 · 2 generations on3descendants
- K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −1 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| 0 (this device) | K042291 | Unicel DXC 600 and 800 Synchron Systems | Beckman Coulter, Inc. | 2004 | — |
| +1 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +1 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +1 | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
| +3 | K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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), 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 CEM? 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 CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX…Summary page 1…ISYNCHRON PRO Systems LX®20 Beckman Coulter, Inc.* K(965240, K(011213 'Beckman Coulter, In… | 1997 |
| * | K011213 | Modification to Synchron LX 20 Clinical Chemistry SystemSummary page 1…LX®20 Beckman Coulter, Inc.* K(965240, K(011213 'Beckman Coulter, Inc., Brea, CA 5.0 Description: The UniCel [)xC 600 and 800 Systems are the next genera… | 2001 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020 | 5 |
| K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020 | 4 |
| K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020 | 4 |
| K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System… | 2011 | 0 |
| K071283 | Synchron Systems Creatinine Reagent | 2007 | 0 |
| K060935 | Synchron Systems Creatinine (Crea) Reagent | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2020 | Class II | Z-2136-2020 | Process control | 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 the body acid-base balance, has a low pH… |
| Dec 5, 2018 | Class II | Z-1078-2019 | Under Investigation by firm | 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 the creation of an aliquot and lead… |
| Aug 21, 2014 | Class II | Z-2687-2014 | Under Investigation by firm | 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 Immunoassay Systems, UniCel DxC 660i, 680i, and… |
| May 14, 2014 | Class II | Z-1737-2014 | Mixed-up of materials/components | 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 | Nonconforming Material/Component | 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 | Software change control | 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 to Barcode Reader becomes misaligned… |
| Jul 6, 2012 | Class II | Z-0059-2013 | Nonconforming Material/Component | 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 numbers between 547 and 574 may cause… |
| Oct 13, 2011 | Class II | Z-2257-2012 | Software design | 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 | Software design | 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 | Software design | 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 | Process design | 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 | Pending | 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 area in one push. The first rack of the… |
| Jan 26, 2011 | Not classified | Z-1940-2011 | Pending | 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 area in one push. The first rack of the… |
| Jan 26, 2011 | Not classified | Z-1939-2011 | Pending | 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 area in one push. The first rack of the… |
| Nov 16, 2010 | Not classified | Z-1972-2011 | Pending | 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 could be cut by the hose clamps, which… |
| Oct 22, 2010 | Not classified | Z-2075-2011 | 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 22, 2010 | Not classified | Z-2077-2011 | 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 22, 2010 | Not classified | Z-2076-2011 | 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 22, 2010 | Not classified | Z-2078-2011 | 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 22, 2010 | Not classified | Z-2080-2011 | 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 22, 2010 | Not classified | Z-2081-2011 | 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 22, 2010 | Not classified | Z-2074-2011 | 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 22, 2010 | Not classified | Z-2079-2011 | 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 22, 2010 | Not classified | Z-2073-2011 | 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… |
| Jul 6, 2010 | Not classified | Z-2686-2011 | Software design | 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 database. The changed sample type… |
| 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 4, 2010 | Not classified | Z-0863-2010 | Device Design | 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 | Pending | 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. The impact of this issue would… |
| Apr 5, 2007 | Not classified | Z-1099-2008 | 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… |
| Apr 5, 2007 | Not classified | Z-1101-2008 | 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… |
| Apr 5, 2007 | Not classified | Z-1100-2008 | 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… |
| Apr 5, 2007 | Not classified | Z-1097-2008 | 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-0902-06 | 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 versions 1.0 &… |
The 5 latest of 34 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K183688 (Abbott Point of Care, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K965240.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEM
1in 2025
2007high 4 (2012) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
2007high 195 (2010) · low 74 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
2007high 12 (2010) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
2007high 245 (2008) · low 4 (2014)2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042291: Unicel DXC 600 and 800 Synchron Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042291
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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