Events

Recall of Device Recall Perkin Elmer Genetic Screening Processor (GSP)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Perkinelmer.

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
    62512
  • Event Risk Class
    Class 2
  • Event Number
    Z-2121-2012
  • Event Initiated Date
    2012-06-27
  • Event Date Posted
    2012-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110801
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Reason
    Contamination from gsp shaker unit results in decreased signal activity of assay measurements for genetic screening for neonatal irt, tsh and irt.
  • Action
    PerkinElmer sent an Urgent: Medical Device Recall letter dated June 27, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that replacement units of the recalled product will be installed as soon as they are available. Customers were instructed to complete and return the response form attached. For further information contact your local PerkinElmer representative or GS. Technical.Support@PerkinElmer.com

Device

Device Recall Perkin Elmer Genetic Screening Processor (GSP)
  • Model / Serial
    Serial Numbers: 20210001 through 20210078
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
  • Product Description
    Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
  • Manufacturer
    Perkinelmer

Manufacturer

Perkinelmer
  • Manufacturer Address
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA