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LCMS-8050 CL

SHIMADZU CORPORATION · Model 225-19610-55 · UDI-DI 04540217400720

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

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.