Events

Recall of Device Recall Neonatal GALT 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
    26138
  • Event Risk Class
    Class 2
  • Event Number
    Z-0898-03
  • Event Initiated Date
    2003-01-08
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27157
  • 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
    Enzyme Controls (Assayed And Unassayed) - Product Code JJT
  • Reason
    The control cards are incorrectly labeled such that the normal 'n' and abnormal 'a' values are reversed.
  • Action
    The firm notified their customers by letter on 1/8/2003.

Device

Device Recall Neonatal GALT Test Kit
  • Model / Serial
    Lot #115496, Exp. 11/1/03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.
  • Product Description
    Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
  • Manufacturer
    PerkinElmer LIfe Sciences Inc

Manufacturer

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