Medical device recalls Moderate risk

AB Sciex, LLC recalls Citrine Triple Quad Mass Spectrometer, Part Number 5063684

Recall date
August 30, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0040-2024
FDA classification
Class II
Brand / firm
AB Sciex, LLC
Sold / distributed
US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Citrine Triple Quad Mass Spectrometer, Part Number 5063684

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