Home / Recalls / Medical Devices
AB Sciex, LLC recalls API3200MD Mass Spectrometer, Part Number 4466230
Recalled October 11, 2023 · FDA recall Z-0037-2024 · AB Sciex
Hazard
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. · FDA Class II
Units
3
Sold at
US Nationwide.
Description
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.
Product
API3200MD Mass Spectrometer, Part Number 4466230
Manufacturer(s)
AB Sciex, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →