FDA recall Z-0040-2024

AB Sciex, LLC · Class II · device

Product

Citrine Triple Quad Mass Spectrometer, Part Number 5063684

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.

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2023-08-30
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Framingham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0040-2024