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
    26606
  • Event Risk Class
    Class 3
  • Event Number
    Z-1139-03
  • Event Initiated Date
    2003-06-27
  • Event Date Posted
    2003-08-20
  • 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=27982
  • 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
    Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate - Product Code JLJ
  • Reason
    The kits are producing lower values than expected, which may result in an increase of false positive test results.
  • Action
    The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.

Device

Device Recall Neonatal GALT Test Kit
  • Model / Serial
    Lot #164738
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
  • Product Description
    Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
  • Manufacturer
    PerkinElmer Life Sciences Inc

Manufacturer

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