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Citrine QTRAP MS/MS

AB SCIEX (MANUFACTURING) · Model 5050807 · UDI-DI 00842365100540

DOP Prescription
10
510(k) clearances
29
Adverse events
16
Recalls
18
Facilities

Description

The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical field according to their mass.

Recalls

DateFirmReason
2023-08-30AB Sciex, LLCIn 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 possib
2023-08-30AB Sciex, LLCIn 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 possib
2023-08-30AB Sciex, LLCIn 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 possib
2023-08-30AB Sciex, LLCIn 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 possib
2021-10-04AB SCIEXThe 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.
2021-02-01Thermo Fisher ScientificDue to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in
2018-09-24PerkinElmer Health Sciences Canada, Inc.Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and Hotfix 2 software, it is possible for the original data from the last acqu
2018-08-15Agilent Technologies, Inc.When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a
2016-07-19Thermo Finnigan LLCThermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.
2016-06-16Ab SciexMultiQuant 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.