Z-0038-2024Class II

4500MD Triple Quad Mass Spectrometer, Part Number 5032522

Name: Z-0038-2024 4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Creator: AB Sciex, LLC
Published: 2023-08-30
License: https://open.fda.gov/license/

AB Sciex, LLC / initiated 2023-08-30 / Open, Classified / root cause: design

FDA source

AB Sciex, LLC began a recall of 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 on 2023-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0038-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-30
Posted: 2023-10-05
Recalling firm: AB Sciex, LLC
Product: 4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Product code: DOP Mass Spectrometer, Clinical Use
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: An URGENT: RUO and MEDICAL DEVICE FIELD ACTION notification letter dated 7/20/23 was sent to customers. Actions to be taken by the Customer/User: SCIEX will provide a replacement nut for eligible sources and systems. Instructions will be provided to guide you through the replacement of the nut. The replacement parts with installation instructions are estimated to begin shipping in October 2023. SCIEX is currently notifying affected customers of the upcoming countermeasure. Upon availability, SCIEX will send you the replacement nut with instructions on how to install it on the ion source probe. We sincerely apologize for any inconvenience that this may cause you. SCIEX aims to provide you with products of the highest quality. If you have any questions regarding this notice, please contact https://sciex.com/aboutus/ contact-us or https://sciex.com/support/request-support.
Quantity in commerce: 38
Distribution: US Nationwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0037-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05
Z-0038-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05
Z-0039-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05
Z-0040-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05

Product code DOP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)