7 results
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20ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·January 26, 2024
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·October 10, 2023
VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 20, 2019
Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code JJE·December 19, 2024
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·August 9, 2023