Ab Sciex
FDA Regulatory Profile
Ab Sciex appears in FDA public data with 12 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0037-2024, Class II) was initiated on August 30, 2023. Its most recent 510(k) clearance was granted on May 18, 2017.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0037-2024 | Class II | API3200MD Mass Spectrometer, Part Number 4466230 | August 30, 2023 |
| Z-0039-2024 | Class II | Citrine QTRAP Mass Spectrometer, Part Number 5063685 | August 30, 2023 |
| Z-0038-2024 | Class II | 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 | August 30, 2023 |
| Z-0040-2024 | Class II | Citrine Triple Quad Mass Spectrometer, Part Number 5063684 | August 30, 2023 |
| Z-0175-2022 | Class II | Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500 | October 4, 2021 |
| Z-2528-2016 | Class II | AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instr | June 16, 2016 |
| Z-2529-2016 | Class II | AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument | June 16, 2016 |
| Z-2526-2016 | Class II | AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 32 | June 16, 2016 |
| Z-2527-2016 | Class II | AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument | June 16, 2016 |
| Z-1671-2016 | Class II | AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Par | March 25, 2016 |
| Z-1586-2016 | Class II | Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/ | February 24, 2016 |
| Z-2609-2014 | Class II | AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identi | July 15, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN170019 | Vitamin D 200M Assay for the Topaz System | May 18, 2017 |