Mass Spectrometer, Clinical Use
FDA product code DOP · Class I (low risk) · 21 CFR 862.2860 · Clinical Chemistry
10510(k) clearances
0PMA approvals
16recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992163 | Abca Gas Isotope Ratio Mass Spectrometer SystemsDOP · Special | Pdz-Europa , Ltd. | 07/13/1999SE |
| K974322 | Abca-Nt Gas Isotope Ratio Mass Spectrometer SystemDOP · Traditional | Europa Scientific, Ltd. | 12/16/1997SE |
| K880418 | Incos 50 Mass SpectrometerDOP · Traditional | Finnigan Corp. | 05/31/1988SE |
| K880090 | Ion Trap DetectorDOP · Traditional | Finnigan Corp. | 03/15/1988SE |
| K880089 | Finnigan Mat TSQ-70DOP · Traditional | Finnigan Corp. | 02/11/1988SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | The Perkin-Elmer Corp. | 08/11/1987SE |
| K854076 | Mga 2000 Gas AnalyserDOP · Traditional | Airspec , Ltd. | 12/11/1985SE |
| K810938 | Mass Spectrometer-Medspect IIDOP · Traditional | Allied Healthcare Products, Inc. | 04/23/1981SE |
| K770994 | Furnace Autosampler, Model 155DOP · Traditional | Instrumentation Laboratory CO | 08/22/1977SE |
| K770637 | Mercury/Hydride System MHS-1DOP · Traditional | The Perkin-Elmer Corp. | 06/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0040-2024 Class II | Citrine Triple Quad Mass Spectrometer, Part Number 5063684In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | AB Sciex, LLC | 08/30/2023Open, Classified |
| Z-0039-2024 Class II | Citrine QTRAP Mass Spectrometer, Part Number 5063685In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | AB Sciex, LLC | 08/30/2023Open, Classified |
| Z-0038-2024 Class II | 4500MD Triple Quad Mass Spectrometer, Part Number 5032522In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | AB Sciex, LLC | 08/30/2023Open, Classified |
| Z-0037-2024 Class II | API3200MD Mass Spectrometer, Part Number 4466230In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an… | AB Sciex, LLC | 08/30/2023Open, Classified |
| Z-0175-2022 Class II | Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX…The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a… | AB Sciex | 10/04/2021Terminated |
| Z-1202-2021 Class II | Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system… | Thermo Fisher Scientific | 02/01/2021Terminated |
| Z-0513-2019 Class II | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2…Under certain conditions when using PerkinElmer QSight 210 MD mass spectrometer with Simplicity 3Q MD and… | PerkinElmer Health Sciences Canada, Inc. | 09/24/2018Terminated |
| Z-2359-2019 Class II | MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole…When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view… | Agilent Technologies, Inc. | 08/15/2018Terminated |
| Z-2775-2016 Class II | Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0…Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0… | Thermo Finnigan LLC | 07/19/2016Terminated |
| Z-2529-2016 Class II | AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use.…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | Ab Sciex | 06/16/2016Terminated |
| Z-2528-2016 Class II | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | Ab Sciex | 06/16/2016Terminated |
| Z-2527-2016 Class II | AB SCIEX 3200MD QTRAP LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use.…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | Ab Sciex | 06/16/2016Terminated |
| Z-2526-2016 Class II | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF):…MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative… | Ab Sciex | 06/16/2016Terminated |
| Z-1671-2016 Class II | AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS…Under certain conditions, mass spectrometers may report incorrect quantitative results. | Ab Sciex | 03/25/2016Terminated |
| Z-1586-2016 Class II | Analyst MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API…Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an… | Ab Sciex | 02/24/2016Terminated |
| Z-2609-2014 Class II | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic…Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for… | Ab Sciex | 07/15/2014Terminated |