12 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DKB·October 13, 2022
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 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
VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code JJY·October 16, 2020
VITROS XT Chemistry Products ALKP Slides
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CJE·August 5, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CIG·August 5, 2023
VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
FDA Recall
Open, Classified
·Ortho Clinical Diagnostics Inc·Product code JHS·December 11, 2020
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
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CHI·September 12, 2023
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025