FDA Device recall Z-0037-2024
API3200MD Mass Spectrometer, Part Number 4466230
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of API3200MD Mass Spectrometer, Part Number 4466230 by Ab Sciex, citing 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 possi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0037-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-30 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ab Sciex |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers: EQ230011907, EQ230021911, EQ230001901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0037-2024%22
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