AB Sciex, LLC

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 4

Known Identifiers & Locations

FEI Numbers 3008935545
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (4)

Recall # Product Description Initiation Date Status Action
Z-0037-2024 API3200MD Mass Spectrometer, Part Number 4466230 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. 2023-08-30 Open, Classified View Details
Z-0038-2024 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 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. 2023-08-30 Open, Classified View Details
Z-0039-2024 Citrine QTRAP Mass Spectrometer, Part Number 5063685 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. 2023-08-30 Open, Classified View Details
Z-0040-2024 Citrine Triple Quad Mass Spectrometer, Part Number 5063684 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. 2023-08-30 Open, Classified View Details

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