Events

Recall of Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems

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
    73433
  • Event Risk Class
    Class 2
  • Event Number
    Z-1586-2016
  • Event Initiated Date
    2016-02-24
  • Event Date Posted
    2016-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144196
  • 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
    Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
  • Action
    Sciex sent an Urgent Medical Device Correction letter dated February 29, 2016, to all affected US customers via Fedex on March 2, 2016. International customers were notified beginning on March 3, 2016. The letter informed customers of the issue and requests that they take temporary steps to eliminate the potential for erroneous events. In addition, a software update is in development and is expected to be available in approximately 4 weeks. Customers with questions were instructed to contact SCIEX at 1-289-982-2531.

Device

Device Recall AB Sciex API 3200MD, 3200MD QTRAP, Triple Quad, QTRAP 4500MD LC/MS/MS Systems
  • Model / Serial
    Software Versions: Version 1.6.1 and 1.6.2
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM
  • Product Description
    Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 || 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
  • 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