Recall Z-0037-2024— AB Sciex, LLC
Class II · Ongoing
Class II FDA medical device recall by AB Sciex, LLC, initiated 2023-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- AB Sciex, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-30
- Firm location
- Framingham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.