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FDAFDA · Food and drugs·Recall number Z-0040-2024

Citrine Triple Quad Mass Spectrometer, Part Number 5063684

Published October 11, 2023 · Recall initiated: August 30, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's 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

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
AB Sciex, LLC
Distributor
US Nationwide.
Lot
UDI-DI: 00842365100533; Serial Numbers: DE220001803PL, DE230011804, DE230031806, DE230041807, DE230051808, DE230071901, DE230081903, DE230091903, DE230162003, DE230272105, DE230292105, DE240002106, DE240022111, DE240042203
Risk classification
Class II
Area (FDA)
device
Country
United States

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