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    VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code JIS·April 9, 2024

    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code CDP·April 9, 2024

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component

    FDA Recall
    Open, Classified ·QUIDEL ORTHO·Product code LFM·December 5, 2024

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. One sales unit contains 5 cartridges. Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit. Component: No, not a component

    FDA Recall
    Open, Classified ·QUIDEL ORTHO·Product code LFM·December 5, 2024

    VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code LOM·November 27, 2023

    QMS Tacrolimus Calibrators, Product code 10015573

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JIT·November 21, 2023

    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023

    VITROS Immunodiagnostic Products Troponin I ES Calibrators

    FDA Recall
    Open, Classified ·ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom·Product code MMI·June 5, 2023

    VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics·Product code JIT·May 8, 2023

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code PFQ·March 5, 2024

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code PFQ·March 5, 2024

    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·May 9, 2025

    Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·May 9, 2025

    Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·May 9, 2025

    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code KHS·October 25, 2023

    QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code GTY·April 6, 2026

    VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code KHP·July 29, 2025

    Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code KHP·July 29, 2025

    VITROS XT7600 Integrated System

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 22, 2024

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·October 11, 2024