Recall of Device Recall MULTIGENT Acetaminophen

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    in vitro diagnostic - Product Code LDP
  • Reason
    Lipase results are falsely elevated when a multigent acetaminophen test is pipetted immediately before a lipase test from the same sample cup or tube on the architect c8000.
  • Action
    The firm initiated the recall on 06/01/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions for modification to the SmartWash feature in the Lipase Assay Configuration in order to prevent Acetaminophen from contaminating Lipase.


  • Model / Serial
    List Number 2K99-20; Control Numbers: 30455UQ11 & 31046UQ02
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide, including USA, Australia, Brazil, Canada, Chile, El Salvador, Dominican Republic, Ecuador, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Thailand, and Venezuela.
  • Product Description
    MULTIGENT Acetaminophen, List Number 2K99-20
  • Manufacturer


  • Manufacturer Address
    Abbott Laboratories Inc., 820 Mission St, South Pasadena CA 91030-3142
  • Source