# K083173: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Dec 22, 2008 after 56 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941142 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System, Ortho-Clinical Diagnostics, Inc. (2008) Summary page 1.

## Recalls of this device
- Dec 19, 2024 · Class II · Z-1007-2025: 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 t
- Jan 26, 2024 · Class II · Z-1229-2024: 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, configurabl
- Jan 26, 2024 · Class II · Z-1224-2024: 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 res
- Jan 22, 2024 · Class II · Z-1220-2024: 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 erron
- Oct 10, 2023 · Class II · Z-0543-2024: 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
- Aug 9, 2023 · Class II · Z-0008-2024: 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 inten
- May 20, 2020 · Class II · Z-2481-2020: 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: 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: 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: 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: 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: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Feb 20, 2019 · Class II · Z-1289-2019: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Oct 19, 2018 · Class II · Z-0652-2019: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Jan 11, 2018 · Class III · Z-1322-2018: 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 
- Jul 28, 2016 · Class III · Z-2580-2016: 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 a
- Apr 6, 2016 · Class II · Z-1913-2016: 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
- Nov 3, 2015 · Class II · Z-0640-2016: 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 intermitten
- Nov 19, 2014 · Class II · Z-0967-2015: 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 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 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: 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 w
- May 6, 2013 · Class II · Z-1650-2013: 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: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.
- Apr 13, 2011 · Not classified · Z-1072-2012: 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-scre
- Apr 13, 2011 · Not classified · Z-1073-2012: 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-scre

## Indications for use
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.

Source page: https://510kreport.com/device/K083173
Methodology: https://510kreport.com/methodology