510(k) · Cleared
Recalled · Class II · 2024Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Dec 22, 2008 as substantially equivalent to K081543 (Ortho-Clinical Diagnostics, Inc., 2008) after a 56-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 26 times.
- Decided
- Dec 22, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- JLW
- Recalls
- 26
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941142 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK941142 Kodak Ektachem Clinical Chemistry Slide PhenytoinEastman Kodak Company · 1994 · Recalled
- 1 generation backK081543 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- This deviceK083173 Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators…Ortho-Clinical Diagnostics · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941142 | Kodak Ektachem Clinical Chemistry Slide Phenytoin | Eastman Kodak Company | 1994 | 5 |
| −1 | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600… | Ortho-Clinical Diagnostics, Inc. | 2008 | 39 |
| 0 (this device) | K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600… | Ortho-Clinical Diagnostics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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? (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 |
|---|---|---|---|
| * | K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…Summary page 1…viously cleared for use with the VITROS ECi/ECiQ Immunodiagnostic System and VITROS 5600 Integrated System (K081543). The modifications include the use of the VITROS TSH Reagent Pack and Calibrators with the… | 2008 |
| † | K962919 | Vitros Immunodiagnostic System | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2024 | Class II | Z-1007-2025 | Software Design Change | The VITROS 3600 Immunodiagnostic 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… |
| Jan 26, 2024 | Class II | Z-1229-2024 | 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-1224-2024 | 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-1220-2024 | 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-0543-2024 | 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… |
| May 20, 2020 | Class II | Z-2481-2020 | Under Investigation by firm | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| May 20, 2020 | Class II | Z-2480-2020 | Under Investigation by firm | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| May 20, 2020 | Class II | Z-2482-2020 | Under Investigation by firm | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| May 20, 2020 | Class II | Z-2484-2020 | Under Investigation by firm | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| May 20, 2020 | Class II | Z-2483-2020 | Under Investigation by firm | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances |
| Feb 20, 2019 | Class II | Z-1290-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Feb 20, 2019 | Class II | Z-1289-2019 | Software design | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems |
| Oct 19, 2018 | Class II | Z-0652-2019 | Software Manufacturing/Software Deployment | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. |
| Jan 11, 2018 | Class III | Z-1322-2018 | Nonconforming Material/Component | VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration… |
| Jul 28, 2016 | Class III | Z-2580-2016 | Under Investigation by firm | A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process… |
| Apr 6, 2016 | Class II | Z-1913-2016 | 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. |
| Nov 3, 2015 | Class II | Z-0640-2016 | 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 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. |
| Jul 7, 2014 | Class II | Z-2139-2014 | 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… |
| May 6, 2013 | Class II | Z-1650-2013 | 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. |
| Mar 15, 2012 | Not classified | Z-1468-2012 | Nonconforming Material/Component | Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure. |
| Apr 13, 2011 | Not classified | Z-1072-2012 | Software design | Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development Assay Data Disk (ADD) that was available in the on-screen mailbox on the Main Menu System… |
| Apr 13, 2011 | Not classified | Z-1073-2012 | Software design | Ortho Clinical Diagnostics (OCD) received customer complaints regarding the loss of calibration data following the installation of a development Assay Data Disk (ADD) that was available in the on-screen mailbox on the Main Menu System… |
The 5 latest of 26 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 14 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K081543.
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, VITROS 3600 Immunodiagnostic System 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…
Read the full statement (121 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, VITROS 3600 Immunodiagnostic System 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, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS 3600 Immunodiagnostic System
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083173: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083173
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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