Events

Recall of 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 LAS 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
    Recall
  • Event ID
    29979
  • Event Risk Class
    Class 2
  • Event Number
    Z-1499-04
  • Event Initiated Date
    2004-09-08
  • Event Date Posted
    2004-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34903
  • 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
    There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
  • Action
    The firm contacted their consignees by letter sent 9/8/04.

Device

Neonatal Total Galactose Test Kit.
  • Model / Serial
    Lot #244468
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
  • Product Description
    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
  • Manufacturer
    PerkinElmer LAS Inc

Manufacturer

PerkinElmer LAS Inc
  • Manufacturer Address
    PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
  • Source
    USFDA