# K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 23, 2008 after 143 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941142 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964558: Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001), Johnson & Johnson Clinical Diagnostics, Inc. (1996) Summary page 3.
- K941142: Kodak Ektachem Clinical Chemistry Slide Phenytoin, Eastman Kodak Company (1994) Summary page 3.

## Most influential descendants
- K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (2018), 1 descendant of its own
- K190326: VITROS XT Chemistry Products UREA-CREA Slides (2019), 0 descendants of its own
- K083173: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System (2008), 0 descendants of its own

## Recalls of this device
- May 9, 2025 · Class II · Z-2038-2025: 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 she
- Dec 19, 2024 · Class II · Z-1005-2025: 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
- Jan 26, 2024 · Class II · Z-1231-2024: 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-1226-2024: 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-1221-2024: 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-0545-2024: 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
- Mar 10, 2023 · Class II · Z-1556-2023: 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: 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: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Jul 8, 2019 · Class II · Z-2180-2019: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Feb 20, 2019 · Class II · Z-1287-2019: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Feb 20, 2019 · Class II · Z-1288-2019: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
- Oct 19, 2018 · Class II · Z-0650-2019: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
- Aug 15, 2018 · Class II · Z-0079-2019: 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: 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: 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 Inst
- May 9, 2018 · Class II · Z-2344-2018: 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 sa
- Jun 12, 2017 · Class II · Z-0273-2018: 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 Su
- Apr 6, 2016 · Class II · Z-1914-2016: 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
- Feb 16, 2016 · Class II · Z-1348-2016: 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 A
- Dec 21, 2015 · Class II · Z-1074-2016: 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 f
- Nov 3, 2015 · Class II · Z-0641-2016: 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
- Sep 28, 2015 · Class III · Z-0202-2016: 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 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 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 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.
- Sep 8, 2014 · Class II · Z-0078-2015: 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 usin
- Jul 7, 2014 · Class II · Z-2141-2014: 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
- Apr 10, 2014 · Class II · Z-1735-2014: 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 S
- Jun 12, 2013 · Class II · Z-0321-2014: 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: 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: 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: 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
- May 21, 2012 · Class II · Z-2068-2012: 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 qual
- Apr 26, 2012 · Not classified · Z-1699-2012: 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: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.

## 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 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.

Source page: https://510kreport.com/device/K081543
Methodology: https://510kreport.com/methodology