Recall of Device Recall Neonatal Total Galactose Test Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Life Sciences 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 3
  • 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
    Enzymatic Methods, Galactose - Product Code JIA
  • Reason
    The device is not stable throughout its labeled expiration date.
  • Action
    The firm contacted their customers by telephone and facsimile on 5/30/2003.


  • Model / Serial
    Lots: #112785, Exp 6/14/03; and #116002, Exp 7/4/03.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
  • Product Description
    Neonatal Total Galactose Test Kit, Item #NG-4000, Filter #903, contents for 4800 assays.
  • Manufacturer


  • Manufacturer Address
    PerkinElmer Life Sciences Inc, 3985 Eastern Rd, Norton OH 44203
  • Source