510(k) · Cleared
Recalled · Class II · 2021Dimension Vista Integrated System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Jul 11, 2005 as substantially equivalent to K944093 (E.I. Dupont DE Nemours & Co., Inc., 1994) and 9 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1992. 5 later devices descend from it. It has been recalled 32 times.
- Decided
- Jul 11, 2005
- Review
- 74 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 32
- Predicates
- 10
Its longest line of descent runs back 2 generations to K922273 (1992). 13 ancestors in all, the oldest K860021 (1986). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922273 Array (R) 360Beckman Instruments, Inc. · 1992
- 1 generation backK990551 Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
- This deviceK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · cites it directly1descendant
- K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · cites it directly1descendant
- K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · cites it directly0descendants
- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
- K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922273 | Array (R) 360 | Beckman Instruments, Inc. | 1992 | — |
| −1 | K990551 | Igg Flex Reagent Cartridge | Dade Behring, Inc. | 1999 | — |
| 0 (this device) | K051087 | Dimension Vista Integrated System | Dade Behring, Inc. | 2005 | — |
| +1 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +1 | K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110 | Dade Behring, Inc. | 2006 | 3 |
| +1 | K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | 2015 | 5 |
| +2 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
| +2 | K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System… | Dade Behring, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2015 | 2 | 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 JJE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K944093 | Dimension (R) XL Clinical Chemistry SystemSummary page 2…Product Device 510(k) Class Code Dimension Vista 'm 1500 Dimension® XL/RIxL K944093 1 862.2160 JJE Integrated chemistry system clinical chemistry analyzer Dimension VistarTM BUN… | 1994 |
| * | K860021 | Dimension (TM) Clinical Chemistry SystemSummary page 2…K944093 1 862.2160 JJE Integrated chemistry system clinical chemistry analyzer Dimension VistarTM BUN Dimension® BUN K860021 11 862.1770 CDQ Flex® reagent cartridge Flex® reagent cartridge Dimension VistaTM Dime… | 1986 |
| * | K990551 | Igg Flex Reagent CartridgeSummary page 2…Chem I K860021 11 862.1150 EIX Chemistry I Calibrator Calibrator Dimension Vista TM IGG Dimension ® IGG K990551 II 866.5510 CFQ Flex® reagent cartridge Flex® reagent cartridge Dimension Vista TM Protein I N Pr… | 1999 |
| * | K012470 | Modification to N Protein Standard SLSummary page 2…K990551 II 866.5510 CFQ Flex® reagent cartridge Flex® reagent cartridge Dimension Vista TM Protein I N Protein Standard SL K012470 Ii 862.1150 JD( Calibrator Dimension VistaTM Protein I N/T Protein Controls SL K012468 11… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 2…Vista TM Protein I N Protein Standard SL K012470 Ii 862.1150 JD( Calibrator Dimension VistaTM Protein I N/T Protein Controls SL K012468 11 862.1660 JJY Controls H, M, L Dimension VistarM PI[NO Dimension ® PHNO K944932… | 2001 |
| * | K944932 | Phenobarbital Flex Reagent CartridgeSummary page 2…VistaTM Protein I N/T Protein Controls SL K012468 11 862.1660 JJY Controls H, M, L Dimension VistarM PI[NO Dimension ® PHNO K944932 11 862.3660 DLZ Flex® reagent cartridge Flex® reagent cartridge Dimension VistaTM Drug I… | 1994 |
| * | K011035 | Dimension Drug Calibrator, Model DC22BSummary page 2…K944932 11 862.3660 DLZ Flex® reagent cartridge Flex® reagent cartridge Dimension VistaTM Drug I Dimension® Drug K01 1035 I1 862.1150 JIX Calibrator Calibrator Dimension VistaTM MMB Dimension® M… | 2001 |
| * | K970343 | MMB MethodSummary page 2…nsion® Drug K01 1035 I1 862.1150 JIX Calibrator Calibrator Dimension VistaTM MMB Dimension® MMB K970343 El 862.1215 JHY Flex® reagent cartridge Flex® reagent cartridge Dimension VistaTM MMB… | 1997 |
| * | K970336 | MMB CalibratorSummary page 2…K970343 El 862.1215 JHY Flex® reagent cartridge Flex® reagent cartridge Dimension VistaTM MMB Dimension® MMB K970336 El 862.1150 lIT Calibrator Calibrator Dimension VistaTM V-LYTETM Dimension®… | 1997 |
| * | K970330 | Dade Indirect Imt System with TCO2 ElectrodeSummary page 2…nsion® MMB K970336 El 862.1150 lIT Calibrator Calibrator Dimension VistaTM V-LYTETM Dimension® Indirect [MT K970330 II K -862.1600 CEM Integrated Multisensor system (QUikLYTE®) Na-8… | 1997 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2021 | Class II | Z-0330-2022 | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Oct 15, 2021 | Class II | Z-0331-2022 | Software design | Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays |
| Dec 12, 2018 | Class II | Z-1014-2019 | Under Investigation by firm | When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination. |
| Oct 16, 2018 | Class II | Z-0616-2019 | Under Investigation by firm | Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample… |
| Mar 3, 2017 | Class II | Z-1703-2017 | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential for an elevation of greater than 15… |
| Mar 24, 2016 | Class II | Z-1885-2016 | Software design | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse… |
| Mar 24, 2016 | Class II | Z-1886-2016 | Software design | Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse… |
| Feb 16, 2016 | Class II | Z-1622-2016 | Nonconforming Material/Component | Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been… |
| May 21, 2015 | Class II | Z-2054-2015 | Software design (manufacturing process) | Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged… |
| Nov 5, 2014 | Class II | Z-0838-2015 | Device Design | Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on… |
| Aug 28, 2014 | Class II | Z-0024-2015 | Process design | Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for drift over the shelf life of this… |
| Apr 14, 2014 | Class II | Z-1733-2014 | Nonconforming Material/Component | A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard. |
| Oct 7, 2013 | Class II | Z-0851-2014 | Software design | When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the system, and then use the incorrect Flex… |
| Jun 19, 2013 | Class II | Z-2088-2013 | Software Design Change | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be… |
| May 20, 2013 | Class II | Z-0430-2014 | Software design | There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista… |
| Jan 16, 2012 | Not classified | Z-1454-2012 | Software change control | Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use… |
| Oct 31, 2011 | Not classified | Z-0644-2012 | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new… |
| Oct 31, 2011 | Not classified | Z-0645-2012 | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new… |
| Oct 31, 2011 | Not classified | Z-0646-2012 | Material/Component Contamination | Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new… |
| Aug 8, 2011 | Not classified | Z-0031-2012 | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is related to a molding defect with the… |
| Aug 19, 2010 | Not classified | Z-0139-2011 | Other | High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System. |
| Jul 23, 2010 | Not classified | Z-0121-2011 | Other | the EasyLink QCFIRST custom rule does not operate as intended. |
| May 5, 2010 | Not classified | Z-2423-2010 | Nonconforming Material/Component | Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur. |
| Mar 15, 2010 | Not classified | Z-2117-2010 | Process design | Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin. |
| Nov 24, 2009 | Not classified | Z-0980-2010 | Nonconforming Material/Component | Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable. |
| Oct 22, 2009 | Not classified | Z-1037-2010 | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. |
| Oct 22, 2009 | Not classified | Z-1038-2010 | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. |
| Oct 22, 2009 | Not classified | Z-1039-2010 | Other | Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor. |
| Sep 1, 2009 | Not classified | Z-1205-2010 | Software design | Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus… |
| Jul 14, 2009 | Not classified | Z-1991-2009 | Software design | incorrect results may be transmitted to LIS |
| Jun 16, 2009 | Not classified | Z-1017-2010 | Nonconforming Material/Component | Incorrect result: patient sample BUN results reported may be higher or lower than actual level. |
| Jul 3, 2007 | Not classified | Z-1174-2007 | Other | Sample ID and Patient results could be associated with the wrong patient |
The 5 latest of 32 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 13 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K073561 (Dade Behring, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K944093.
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | 0 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.…
Read the full statement (639 words)
The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.
The Dimension Vista™ Urea Nitrogen Flex® reagent cartridge (BUN) is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Dimension Vista™ Chem I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of urea nitrogen in human specimens.
The Dimension Vista™ Immunoglobulin G Flex® reagent cartridge (IGG) is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulin G (serum antibody) in serum and plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The Dimension Vista™ Protein I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of IgG in human specimens.
The Dimension Vista™ Protein I Controls, H, M, L, are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
The Dimension Vista™ Phenobarbital Flex® reagent cartridge (PHNO) is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.
Dimension Vista™ Drug I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of phenobarbital in human specimens.
The Dimension Vista™ Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) is a device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.
The Dimension Vista™ MMB Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of mass creatine kinase MB isoenzyme in human specimens.
The Dimension Vista™ V-LYTE™ Sodium test system is intended to measure sodium in serum, plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The Dimension Vista™ V-LYTE™ Potassium test system is intended to measure potassium in serum, plasma and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterized by low or high blood potassium levels.
The Dimension Vista™ V-LYTE™ Chloride test system is intended to measure chloride in serum, plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Dimension Vista™ V-LYTE™ Standard A and Standard B are intended for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051087: Dimension Vista Integrated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051087
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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