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Recall Observatory FDA recall evidence

Device product

API3200MD Mass Spectrometer, Part Number 4466230

Z-0037-2024

August 30, 2023

Class II

Product summary

Firm
AB Sciex, LLC
Event
Event 92810
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-0037-2024

Official wording

Reason: 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.

Code information: Serial Numbers: EQ230011907, EQ230021911, EQ230001901

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.