RegWardenFDA facility compliance records
Company

AB SCIEX

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2014: 1 recalls; 2016: 3 recalls; 2021: 1 recalls; 2023: 1 recalls1’14’153’16’17’18’19’201’21’221’23’24’25’26
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-08-30
    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 …
  • Class IITerminated2021-10-04
    The values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to hidden and left the column empty. This may lead to the user making incorrect conclusions using incorrect results.
  • Class IITerminated2016-06-16
    MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
  • Class IITerminated2016-03-25
    Under certain conditions, mass spectrometers may report incorrect quantitative results.
  • Class IITerminated2016-02-24
    Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
  • Class IITerminated2014-07-15
    Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “AB SCIEX — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10041672-ab-sciex/

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