Events

Recall of Device Recall PerkinElmer Specimen Gate Screening Center software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by PerkinElmer Health 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
    68670
  • Event Risk Class
    Class 2
  • Event Number
    Z-2166-2014
  • Event Initiated Date
    2014-06-27
  • Event Date Posted
    2014-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128489
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Potential for demographic information and test result to be mismatch.
  • Action
    PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email specimen.gate.support@perkinelmer.com. Customers with questions were instructed to call 1-800-321-9632. option 1.

Device

Device Recall PerkinElmer Specimen Gate Screening Center software
  • Model / Serial
    Product Code: 5002-0500; Software Versions, 1.4 and 1.6
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
  • Product Description
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 || Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • Manufacturer Address
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA