Events

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
    Recall
  • Event ID
    26412
  • Event Risk Class
    Class 3
  • Event Number
    Z-0970-03
  • Event Initiated Date
    2003-05-30
  • Event Date Posted
    2003-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27640
  • 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.

Device

Device Recall Neonatal Total Galactose Test Kit
  • Model / Serial
    Lots: #112785, Exp 6/14/03; and #116002, Exp 7/4/03.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
    PerkinElmer Life Sciences Inc

Manufacturer

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