Ab Sciex, LLC
Also registered as AB Sciex
Country not established
- Devices
- 15
- FDA recalls
- 124 ongoing
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 15 devicesFDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 4
- 2024 0
- 2025 0
- 2026 0
2023
- 30 Aug 2023 Z-0037-2024 Class II Ongoing 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 the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
- 30 Aug 2023 Z-0038-2024 Class II Ongoing 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 the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
- 30 Aug 2023 Z-0039-2024 Class II Ongoing 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 the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
- 30 Aug 2023 Z-0040-2024 Class II Ongoing 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 the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
2021
- 4 Oct 2021 Z-0175-2022 Class II Terminated 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 left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
Full distribution text
- 4 Oct 2021 Z-0175-2022 Class II Terminated 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 left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
2016
- 16 Jun 2016 Z-2526-2016 Class II Terminated MultiQuant MD software where under certain conditions a user
can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Full distribution text
- 16 Jun 2016 Z-2527-2016 Class II Terminated MultiQuant MD software where under certain conditions a user
can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Full distribution text
- 16 Jun 2016 Z-2528-2016 Class II Terminated MultiQuant MD software where under certain conditions a user
can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Full distribution text
- 16 Jun 2016 Z-2529-2016 Class II Terminated MultiQuant MD software where under certain conditions a user
can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Full distribution text
- 25 Mar 2016 Z-1671-2016 Class II Terminated Under certain conditions, mass spectrometers may report incorrect quantitative results.
- 16 Jun 2016 Z-2526-2016 Class II Terminated MultiQuant MD software where under certain conditions a user
can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Show all 12 recalls
2016
- 24 Feb 2016 Z-1586-2016 Class II Terminated Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Full distribution text
- 24 Feb 2016 Z-1586-2016 Class II Terminated Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
2014
- 15 Jul 2014 Z-2609-2014 Class II Terminated Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Frequently asked questions
How many devices does Ab Sciex, LLC have in the registry?
The registry currently lists 15 devices for Ab Sciex, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ab Sciex, LLC's devices?
Among its 15 most recently registered devices, Ab Sciex, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ab Sciex, LLC's devices fall under?
Among its 15 most recently registered devices, the classes recorded for Ab Sciex, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ab Sciex, LLC?
FDA recall records list 12 recalls initiated by Ab Sciex, LLC, the most recent initiated on 30 Aug 2023. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ab Sciex, LLC in the registry?
The most recently registered devices listed for Ab Sciex, LLC include Vitamin D 200 Series 5044487, Vitamin D 200 Series 5044490, Vitamin D 200 Series 5045360 and Vitamin D 200 Series 5044491.