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FDAAugust 30, 2023device

API3200MD Mass Spectrometer, Part Number 4466230

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

ab sciex

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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