FDA-Device2023-10-11Class II
API3200MD Mass Spectrometer, Part Number 4466230
AB Sciex, LLC
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.
Sold states
US Nationwide.
Affected count
3
Manufactured in
500 Old Connecticut Path, N/A, Framingham, MA, United States
Products
API3200MD Mass Spectrometer, Part Number 4466230
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0037-2024Don't want to check this manually?
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