510(k) · Cleared
Recalled · Class II · 2023Unicel DXC 600I Synchron Access Clinical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CFR Hexokinase, Glucose
Cleared on Feb 27, 2006 as substantially equivalent to K023049 (Beckman Coulter, Inc., 2002) after a 26-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled 24 times.
- Decided
- Feb 27, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 24
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011213 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011213 Modification to Synchron LX 20 Clinical Chemistry SystemBeckman Coulter, Inc. · 2001 · Recalled
- 1 generation backK023049 Synchron LX I 725 Clinical SystemBeckman Coulter, Inc. · 2002 · Recalled
- This deviceK060256 Unicel DXC 600I Synchron Access Clinical SystemBeckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK103842 Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC…Beckman Coulter, Inc. · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K103842Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System…Beckman Coulter, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | Beckman Coulter, Inc. | 2001 | 11 |
| −1 | K023049 | Synchron LX I 725 Clinical System | Beckman Coulter, Inc. | 2002 | 18 |
| 0 (this device) | K060256 | Unicel DXC 600I Synchron Access Clinical System | Beckman Coulter, Inc. | 2006 | — |
| +1 | K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800… | Beckman Coulter, Inc. | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…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? (1)
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 |
|---|---|---|---|
| * | K023049 | Synchron LX I 725 Clinical SystemSummary page 1…se [862.2160] 4.0 Legally Marketed Device The UniCel DxC 600i System claims substantial equivalence to the SYNCHRON LXi 725 System (Docket Number K023049) currently in commercial distribution. 5.0 Device Description The UniCel DxC 600i System combines the UniCel DxC 60… | 2002 |
| † | K042291 | Unicel DXC 600 and 800 Synchron Systems | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103842 | Unicel DXC 600 Synchron System Software Version 5.0 and Unicel DXC 800 Synchron System… | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2023 | Class II | Z-1257-2023 | Component change control | An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a… |
| Nov 6, 2017 | Class III | Z-0310-2018 | Device Design | Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment. |
| Oct 6, 2014 | Class II | Z-0176-2015 | Vendor change control | Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a "MFC Exception" error during normal operation of the analyzer system. |
| 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. |
| Feb 12, 2013 | Class II | Z-1035-2013 | Device Design | Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley… |
| Nov 1, 2012 | Class II | Z-0612-2013 | Device Design | It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at… |
| 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… |
| 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 5, 2010 | Not classified | Z-1936-2011 | Pending | The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and… |
| Aug 13, 2010 | Not classified | Z-0607-2011 | Pending | This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of… |
| 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. |
| Feb 25, 2010 | Not classified | Z-2590-2010 | Other | Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may… |
| Jan 18, 2010 | Not classified | Z-2442-2010 | Other | The recall was initiated due to " A loose Aliquot Probe tube fitting in the Closed Tube Aliquotter (CTA), may result in erroneous Access immunoassay results or Synchron chemistry results". This may result in dilution of the sample with… |
| 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. |
| Oct 28, 2009 | Not classified | Z-0856-2010 | Software design | This recall was initiated because of software issue was identified in System Software 4.2 and 4.2.1, which may result in the incorrect handling of a wash arm dispense plate motion failure. Instead of generating a red warning event and… |
| 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… |
| May 7, 2009 | Not classified | Z-2771-2011 | Software design | The recall was initiated after Beckman Coulter confirmed reports of inaccurate Access Intrinsic Factor Ab test results displayed on, or printed from, the UniCel Dxl portion of an integrated workstation listed above. The problem is limited… |
| Oct 9, 2008 | Not classified | Z-0914-2010 | Other | The recall was initiated after Beckman Coulter confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is… |
| Sep 11, 2008 | Not classified | Z-1375-2012 | Software design | The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay. |
| Apr 3, 2008 | Not classified | Z-2386-2008 | Nonconforming Material/Component | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. |
| Oct 17, 2007 | Not classified | Z-1183-2008 | Process control | Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering. |
| Apr 5, 2007 | Not classified | Z-1098-2008 | 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… |
The 5 latest of 24 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 5 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K103842 (Beckman Coulter, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023049.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements. The UniCel DxC 600 Synchron® Clinical System is a fully…
Read the full statement (176 words)
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements.
The UniCel DxC 600 Synchron® Clinical System is a fully automated, computer-controlled clinical chemistry analyzer 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).
The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic in particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060256: Unicel DXC 600I Synchron Access Clinical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060256
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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