PlainRecalls
FDA Devices Moderate Class II Ongoing

4500MD Triple Quad Mass Spectrometer, Part Number 5032522

Reported: October 11, 2023 Initiated: August 30, 2023 #Z-0038-2024

Product Description

4500MD Triple Quad Mass Spectrometer, Part Number 5032522

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
38
Distribution
US Nationwide.
Location
Framingham, MA

Frequently Asked Questions

What product was recalled?
4500MD Triple Quad Mass Spectrometer, Part Number 5032522. Recalled by AB Sciex, LLC. Units affected: 38.
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-0038-2024.