Ab Sciex
Medical device manufacturer in Framingham, MA.
0510(k) clearances
0PMA approvals
12recalls
Recalls
| Recall | Product | 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… | 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… | 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… | 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… | 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… | 10/04/2021Terminated |
| 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… | 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… | 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… | 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… | 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. | 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… | 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… | 07/15/2014Terminated |