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Sources: EU EUDAMED, US FDA
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FDA Recall
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AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·July 15, 2014
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·March 25, 2016
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·June 16, 2016
AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·June 16, 2016
AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·June 16, 2016
AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5024500 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·June 16, 2016
Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
FDA Recall
Terminated
·Ab Sciex·Product code DOP·February 24, 2016
Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
FDA Recall
Terminated
·AB SCIEX·Product code DOP·October 4, 2021
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
FDA Recall
Open, Classified
·AB Sciex, LLC·Product code DOP·August 30, 2023
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
FDA Recall
Open, Classified
·AB Sciex, LLC·Product code DOP·August 30, 2023
API3200MD Mass Spectrometer, Part Number 4466230
FDA Recall
Open, Classified
·AB Sciex, LLC·Product code DOP·August 30, 2023
Citrine QTRAP Mass Spectrometer, Part Number 5063685
FDA Recall
Open, Classified
·AB Sciex, LLC·Product code DOP·August 30, 2023