16 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Enforcement
Class II
·Terminated·Ortho Clinical Diagnostics·July 8, 2020
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code JJE·May 20, 2020
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·May 15, 2019
VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·December 26, 2018
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: 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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·July 10, 2013
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·June 15, 2016
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. 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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 21, 2015
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.
FDA Enforcement
Class II
·Terminated·Medical Positioning Inc·August 20, 2014
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: 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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·January 20, 2016
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,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·April 6, 2016
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: 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·May 6, 2013
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. 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·November 19, 2014
VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 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
VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: 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·November 3, 2015
VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: 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·April 13, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012