Events

Recall of Device Recall Perkin Elmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Life and Analytical Sciences, Wallac, OY.

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
    61031
  • Event Risk Class
    Class 2
  • Event Number
    Z-1116-2012
  • Event Initiated Date
    2012-01-09
  • Event Date Posted
    2012-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107141
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • Reason
    Gsp instruments with defective washer modules may cause a false negative screening result being reported for t4, tsh and irt. for 17-ohp, a false positive result may be generated if the failure occurs for a normal sample.
  • Action
    Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.

Device

Device Recall Perkin Elmer
  • Model / Serial
    Serial numbers from 20210012 to 20210021
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
  • Product Description
    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Manufacturer Address
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA