PlainRecalls
FDA Devices Moderate Class II Ongoing

API3200MD Mass Spectrometer, Part Number 4466230

Reported: October 11, 2023 Initiated: August 30, 2023 #Z-0037-2024

Product Description

API3200MD Mass Spectrometer, Part Number 4466230

Reason for Recall

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.

Details

Recalling Firm
AB Sciex, LLC
Units Affected
3
Distribution
US Nationwide.
Location
Framingham, MA

Frequently Asked Questions

What product was recalled?
API3200MD Mass Spectrometer, Part Number 4466230. Recalled by AB Sciex, LLC. Units affected: 3.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-0037-2024.