Home › Device types › DOP
Mass Spectrometer, Clinical Use
FDA product code DOP · Class 1 · Clinical Chemistry
36
Registered devices
29
Adverse events
16
Recalls
10
510(k) clearances
Devices with this code
LCMS-8045CL — SHIMADZU CORPORATIONSpectroChip CPM Kit (10x96) — AGENA BIOSCIENCE, INC.Sercon — SERCON LIMITEDLCMS-8050 CL — SHIMADZU CORPORATIONQsight 210 MD Screening System — Wallac Oycobas i 601 SBL — Roche Diagnostics GmbHAB SCIEX QTRAP® 4500MD — AB SCIEX (MANUFACTURING)CPM Dx — AGENA BIOSCIENCE, INC.Xevo — WATERS TECHNOLOGIES CORPORATIONLCMS-8040 CL — SHIMADZU CORPORATIONTriple Quad™ 4500MD — AB SCIEX (MANUFACTURING)SpectroChip CPM Kit (2x96) — AGENA BIOSCIENCE, INC.Xevo — WATERS TECHNOLOGIES CORPORATIONCitrine Triple Quad™ MS/MS — AB SCIEX (MANUFACTURING)SpectroChip Standalone Chip Only) — AGENA BIOSCIENCE, INC.APCI-8050 SET — SHIMADZU CORPORATIONQsight 225 MD Screening System — Wallac OyCitrine QTRAP MS/MS — AB SCIEX (MANUFACTURING)MassARRAY Clean Resin 28g — AGENA BIOSCIENCE, INC.AB SCIEX Triple Quad™ 4500MD — AB SCIEX (MANUFACTURING)MassARRAAY Dx — AGENA BIOSCIENCE, INC.LCMS-8060 CL — SHIMADZU CORPORATIONcobas i 601 — Roche Diagnostics GmbHCalibrant — AGENA BIOSCIENCE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-30 | AB Sciex, LLC | 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 |
| 2023-08-30 | AB Sciex, LLC | 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 |
| 2023-08-30 | AB Sciex, LLC | 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 |
| 2023-08-30 | AB Sciex, LLC | 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 |
| 2021-10-04 | AB SCIEX | 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 lef |
| 2021-02-01 | Thermo Fisher Scientific | Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the corr |
| 2018-09-24 | PerkinElmer 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 dat |
| 2018-08-15 | Agilent 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. Th |
| 2016-07-19 | Thermo Finnigan LLC | Thermo 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 |
| 2016-06-16 | Ab Sciex | 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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