fda
10 records
FDA Device Recall: Citrine Triple Quad Mass Spectrometer, Part Number 5063684
2023-10-11
Class II — In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejecti...
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FDA Device Recall: 4500MD Triple Quad Mass Spectrometer, Part Number 5032522
2023-10-11
Class II — In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejecti...
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FDA Device Recall: Cliquid MD version 3.4 software used in conjunction with Analyst MD software on
2021-11-03
Class II — The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may ...
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FDA Recall: Ab Sciex — Class II
20160824
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions fe | Product: AB Sciex API 3200MD" LC/MS/MS System. ...
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FDA Device Recall: AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Numbe
2016-08-24
Class II — MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
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FDA Device Recall: AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnost
2016-08-24
Class II — MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
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FDA Device Recall: AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnost
2016-08-24
Class II — MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
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FDA Device Recall: AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD
2016-05-25
Class II — Under certain conditions, mass spectrometers may report incorrect quantitative results.
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FDA Device Recall: Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments
2016-05-11
Class II — Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
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FDA Device Recall: AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro
2014-09-17
Class II — Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
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ny_corps
1 records
NY Corp: AB SCIEX LLC
2009-11-02
FOREIGN LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: Delaware
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