Data Foundry

Medical device recalls 2023

API3200MD Mass Spectrometer — Class II medical device recall Z-0037-2024

Ongoing recall by AB Sciex, LLC, reported 2023-10-11, distributed nationwide. In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an ele

Recall numberZ-0037-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAB Sciex, LLC, Framingham, MA, United States
Recall initiated2023-08-30
Classified2023-10-05
Reported by FDA2023-10-11
DistributedNationwide (US)
Quantity3
Reason classespackaging
Serial numbersEQ230001901, EQ230011907, EQ230021911
Model numbers4466230

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0037-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.