510(k) · Cleared
Recalled · Class II · 2019Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Nov 13, 2006 after a 28-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 35 times.
- Decided
- Nov 13, 2006
- Review
- 28 days
- Class
- Class I
- Product code
- JJE
- Recalls
- 35
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK063144 Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemOrtho-Clinical Diagnostics, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK160495 VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc. · 2016 · cites it directly2descendants
- K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · 2 generations on1descendant
- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +1 | K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016 | 1 |
| +2 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +3 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | — | VITROS dHDL assay performed on the VITROS 5,1 FS Chemistry System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160495 | VITROS® Automation Solutions | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2019 | Class II | Z-2181-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2184-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2183-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2182-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Oct 19, 2018 | Class II | Z-0651-2019 | Software Manufacturing/Software Deployment | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. |
| Oct 19, 2018 | Class II | Z-0653-2019 | Software Manufacturing/Software Deployment | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. |
| Apr 26, 2017 | Class II | Z-0254-2018 | Software design (manufacturing process) | A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track |
| Mar 8, 2017 | Class II | Z-2077-2017 | Software design | Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen… |
| Sep 7, 2016 | Class II | Z-0300-2017 | Software design | Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the… |
| May 16, 2016 | Class III | Z-2143-2016 | Software design | If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text… |
| Mar 17, 2016 | Class II | Z-1569-2016 | Component design/selection | The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped… |
| Dec 21, 2015 | Class II | Z-1075-2016 | Error in labeling | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition… |
| Dec 21, 2015 | Class II | Z-1073-2016 | Error in labeling | Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition… |
| Nov 3, 2015 | Class II | Z-0643-2016 | Software design | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems… |
| Nov 3, 2015 | Class II | Z-0642-2016 | Software design | Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems… |
| Sep 10, 2015 | Class II | Z-0231-2016 | Software design | Software Anomaly during ADD Installation on VITROS 5,1 FS Chemistry Systems using Software Versions 2.2.1 through 2.8. The user modified parameters would not be saved as expected, but remained changed to the default values obtained from… |
| May 6, 2015 | Class II | Z-1724-2015 | Component change control | Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These… |
| Apr 6, 2015 | Class II | Z-1729-2015 | Software design | Software anomaly regarding urine samples that require acidified pretreatment. The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no… |
| Mar 10, 2015 | Class II | Z-1521-2015 | Software in the Use Environment | Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series… |
| Nov 19, 2014 | Class II | Z-0967-2015 | Software design | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration. |
| Nov 19, 2014 | Class II | Z-0969-2015 | Software design | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration. |
| Nov 19, 2014 | Class II | Z-0968-2015 | Software design | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration. |
| Sep 29, 2014 | Class III | Z-1004-2015 | Software Manufacturing/Software Deployment | Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. |
| Sep 8, 2014 | Class II | Z-0077-2015 | Software design | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied… |
| Jul 7, 2014 | Class II | Z-2140-2014 | Software in the Use Environment | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample… |
| Apr 17, 2014 | Class II | Z-1741-2014 | Software Design Change | Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5. |
| Apr 10, 2014 | Class II | Z-1736-2014 | Software design | Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with… |
| Apr 10, 2014 | Class II | Z-1738-2014 | Software design | Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh… |
| Mar 20, 2014 | Class II | Z-1677-2014 | Software design | Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage… |
| Jun 6, 2013 | Class II | Z-1948-2013 | Nonconforming Material/Component | Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement. |
| Feb 7, 2013 | Class II | Z-1106-2013 | Nonconforming Material/Component | Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal… |
| Mar 15, 2012 | Not classified | Z-1471-2012 | Nonconforming Material/Component | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
| Mar 15, 2012 | Not classified | Z-1472-2012 | Nonconforming Material/Component | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
| Apr 28, 2011 | Not classified | Z-0914-2012 | Component design/selection | Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured… |
| May 17, 2007 | Not classified | Z-1167-2007 | Other | Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS Chemistry Products THC Reagent. A… |
The 5 latest of 35 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160495 (Ortho-Clinical Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
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
2007high 3 (2014) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
2007high 224 (2014)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
2007high 32 (2010) · low 0 (2022)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
2007high 11,606 (2011) · low 1,869 (2017)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 VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063144: Vitros 5,1 FS Chemistry System with Engen Laboratory Automation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063144
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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