Ab Sciex

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0037-2024Class IIAPI3200MD Mass Spectrometer, Part Number 4466230August 30, 2023
Z-0039-2024Class IICitrine QTRAP Mass Spectrometer, Part Number 5063685August 30, 2023
Z-0038-2024Class II4500MD Triple Quad Mass Spectrometer, Part Number 5032522August 30, 2023
Z-0040-2024Class IICitrine Triple Quad Mass Spectrometer, Part Number 5063684August 30, 2023
Z-0175-2022Class IICliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500October 4, 2021
Z-2528-2016Class IIAB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. InstrJune 16, 2016
Z-2529-2016Class IIAB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument June 16, 2016
Z-2526-2016Class IIAB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 32June 16, 2016
Z-2527-2016Class IIAB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument June 16, 2016
Z-1671-2016Class IIAB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, ParMarch 25, 2016
Z-1586-2016Class IIAnalyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/February 24, 2016
Z-2609-2014Class IIAB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identiJuly 15, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
DEN170019Vitamin D 200M Assay for the Topaz SystemMay 18, 2017