Events

Recall of Device Recall AB SciexTriple Quad 4500MD LC/MS/MS System.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ab Sciex.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73786
  • Event Risk Class
    Class 2
  • Event Number
    Z-1671-2016
  • Event Initiated Date
    2016-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144977
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mass spectrometer, clinical use - Product Code DOP
  • Reason
    Under certain conditions, mass spectrometers may report incorrect quantitative results.
  • Action
    AB SCIEX issued Urgent: Medical Device Correction letter, dated 3/25/16, advising user of the problem and advising not to use the system until corrected. The letter also discussed the risk to health, as well as how to recognize if the issue has occurred. Sciex Field Service Employee (FSE) will be sent to customer site to perform the field corrective action on the affected system. Questions regarding the letter should be directed to SCIEX at 1-289-982-2531.

Device

Device Recall AB SciexTriple Quad 4500MD LC/MS/MS System.
  • Model / Serial
    Serial Numbers:  Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602  QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to the state of NC.
  • Product Description
    AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. || Mass spectrometers for in vitro diagnostic use only.
  • Manufacturer
    Ab Sciex

Manufacturer

Ab Sciex
  • Manufacturer Address
    Ab Sciex, 500 Old Connecticut Path, Framingham MA 01701-4574
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA