FDA Device recall Z-0038-2024
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 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-0038-2024 |
| 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
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
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 | UDI-DI: 00842365102049; Serial Numbers: EJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ23012181…UDI-DI: 00842365102049; Serial Numbers: EJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ230121811, EJ230141811, EJ230151812, EJ230161812, EJ230171901, EJ230181901, EJ230191901, EJ230211905, EJ230221908, EJ230231908, EJ230251909, EJ230271910, EJ230281910, EJ230311911, EJ230331912, EJ230362003, EJ230372003, EJ230392004, EJ230412009, EJ230422011, EJ230442012, EJ230452012, EJ230472101, EJ230482103, EJ230512105, EJ240012110, EJ240022111, EJ240052111, EJ240082207, EJ240092209, EJ240142307, EJ240132305, EJ240062201 |
|---|
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-0038-2024%22
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