RegWardenFDA facility compliance records
Facility

AB SCIEX LP

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2016: 3 recalls, 1 inspections; 2021: 1 recalls; 2023: 1 recalls1’14’154’16’17’18’19’201’21’221’23’24’25’26
  • Recalls (6)
  • Inspections (1)

Devices registered here (1)

  • Mass Spectrometer, Clinical Use
    Product code DOP (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2860

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

FDA inspections (1)

  • VAI2016-01-28
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AB SCIEX LP (FEI 3008336863) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008336863-ab-sciex-lp/

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