Events

Recall of Device Recall PantheraPuncher 9 .

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
    68686
  • Event Risk Class
    Class 2
  • Event Number
    Z-2153-2014
  • Event Initiated Date
    2014-07-01
  • Event Date Posted
    2014-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128446
  • 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
    Panthera-Puncher 9 . - Product Code ooo
  • Reason
    Risk of incorrect results from samples prepared with panthera-puncher 9.
  • Action
    Perkin Elmer sent an Urgent Medical Device Recall letter dated July 1, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Recall Letter delivered to the end customer by email facilitated through our Perkin Elmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: "Removing the plates from the Panthera-Puncher 9 when not actively punching and processing samples in the instrument. "Opening the plate track hatch if plates must reside in the Panthera-Puncher 9 while the instrument is idle or in sleep mode. This will interrupt power to the ionizer and eliminate any ionizer impact on the plate wells. For further information, please contact your local Perkin Eimer representative or GSTechnicaiSupport@PerkinEimer.com. For further information please call (781) 663-6900.

Device

Device Recall PantheraPuncher 9 .
  • Model / Serial
    Serial Numbers: 20810001 through 20810148
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
  • Product Description
    Panthera-Puncher 9 . || Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
  • 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