510(k) · Cleared
Recalled · Class II · 2025Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Oct 23, 2008 as substantially equivalent to K964558 (Johnson & Johnson Clinical Diagnostics, Inc., 1996) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it. It has been recalled 39 times.
- Decided
- Oct 23, 2008
- Review
- 143 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 39
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941142 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941142 Kodak Ektachem Clinical Chemistry Slide PhenytoinEastman Kodak Company · 1994 · Recalled
- This deviceK081543 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK182063 VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK190326 VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK083173 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics · 2008 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc. · 2018 · cites it directly1descendant
- K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 2 generations on0descendants
- K083173Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…Ortho-Clinical Diagnostics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941142 | Kodak Ektachem Clinical Chemistry Slide Phenytoin | Eastman Kodak Company | 1994 | 5 |
| 0 (this device) | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | Ortho-Clinical Diagnostics, Inc. | 2008 | — |
| +1 | K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides… | Ortho-Clinical Diagnostics, Inc. | 2018 | 20 |
| +2 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +1 | K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600… | Ortho-Clinical Diagnostics | 2008 | 26 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 JLW? 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 JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)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 |
|---|---|---|---|
| * | K964558 | Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001)Summary page 3…Products TSH Assay is substantially equivalent to the product previously cleared with Premarket Notification number K964558. The VITROS Chemistry Products PHYT Assay is substantially equivalent to th… | 1996 |
| * | K941142 | Kodak Ektachem Clinical Chemistry Slide PhenytoinSummary page 3…roducts PHYT Assay is substantially equivalent to the product previously cleared with Premarket Notification number K941142. 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 1994 |
| † | K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator… | 2003 |
| † | K962919 | Vitros Immunodiagnostic System | 1996 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| May 9, 2025 | Class II | Z-2038-2025 | Software design | A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during… |
| Dec 19, 2024 | Class II | Z-1005-2025 | Software Design Change | The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would… |
| Jan 26, 2024 | Class II | Z-1231-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not… |
| Jan 26, 2024 | Class II | Z-1226-2024 | Software Design Change | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. |
| Jan 22, 2024 | Class II | Z-1221-2024 | Component change control | Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results. |
| Oct 10, 2023 | Class II | Z-0545-2024 | Under Investigation by firm | During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or… |
| Aug 9, 2023 | Class II | Z-0008-2024 | Under Investigation by firm | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification… |
| Mar 10, 2023 | Class II | Z-1556-2023 | Under Investigation by firm | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable |
| Mar 10, 2023 | Class II | Z-1557-2023 | Under Investigation by firm | MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿ 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable |
| Jul 8, 2019 | Class II | Z-2179-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Jul 8, 2019 | Class II | Z-2180-2019 | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System |
| Feb 20, 2019 | Class II | Z-1287-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Feb 20, 2019 | Class II | Z-1288-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Oct 19, 2018 | Class II | Z-0650-2019 | Software Manufacturing/Software Deployment | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. |
| Aug 15, 2018 | Class II | Z-0079-2019 | Software design | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. |
| Aug 15, 2018 | Class II | Z-0080-2019 | Software design | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. |
| Jul 12, 2018 | Class II | Z-0061-2019 | Device Design | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who… |
| May 9, 2018 | Class II | Z-2344-2018 | Under Investigation by firm | There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples. |
| Jun 12, 2017 | Class II | Z-0273-2018 | Device Design | The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin… |
| Apr 6, 2016 | Class II | Z-1914-2016 | Software design | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results. |
| Feb 16, 2016 | Class II | Z-1348-2016 | Process control | The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged. |
| Dec 21, 2015 | Class II | Z-1074-2016 | 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-0641-2016 | 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 28, 2015 | Class III | Z-0202-2016 | Under Investigation by firm | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954. |
| Apr 6, 2015 | Class II | Z-1743-2015 | Software design | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results. |
| Apr 6, 2015 | Class II | Z-1742-2015 | Software design | Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results. |
| 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 8, 2014 | Class II | Z-0078-2015 | 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-2141-2014 | 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 10, 2014 | Class II | Z-1735-2014 | 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… |
| Jun 12, 2013 | Class II | Z-0321-2014 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 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. |
| May 6, 2013 | Class II | Z-1649-2013 | Device Design | There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt. |
| Feb 7, 2013 | Class II | Z-1108-2013 | 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… |
| May 21, 2012 | Class II | Z-2068-2012 | Software design | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment. |
| Apr 26, 2012 | Not classified | Z-1699-2012 | Software design | Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position. |
| Mar 15, 2012 | Not classified | Z-1470-2012 | Nonconforming Material/Component | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
The 5 latest of 39 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182063 (Ortho-Clinical Diagnostics, Inc., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, 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 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VITROS Immunodiagnostic Products TSH Reagent Pack For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease. VITROS Immunodiagnostic Products TSH Calibrators For in vitro use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS…
Read the full statement (208 words)
VITROS Immunodiagnostic Products TSH Reagent Pack
For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
VITROS Immunodiagnostic Products TSH Calibrators
For in vitro use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS Chemistry Products PHYT Slides
For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.
VITROS Chemistry Products Calibrator Kit 9
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT.
VITROS 5600 Integrated System
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081543
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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