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.

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
    71380
  • Event Risk Class
    Class 2
  • Event Number
    Z-2126-2015
  • Event Initiated Date
    2015-06-03
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137591
  • 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
    Counter (beta, gamma) for clinical use - Product Code JJJ
  • Reason
    Error in wizard2 barcode id label #023 content may produce erroneous results.
  • Action
    Perkin Elmer issued the recall letter on June 3, 2015. Action to be taken: Until the PerkinElmer correction has been completed, we request you immediately destroy all barcode ID labels #023 in your possession. The WIZARD Gamma Counter barcode label binder contains a total of 20 barcode labels identified as #023 (i.e. 2 labels on each of 10 pages). Please ensure you remove the barcode labels ID #023 from all barcode label binders in your possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer. Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com

Device

Device Recall Perkin Elmer
  • Model / Serial
    Serial Numbers: DG03130211 DG04130287 DG05130344 DG06129306 DG08129516 DG08129541 DG08129542 DG08129582 DG08129593 DG10129714 DG10129720 DG11095720 DG12118684 DG12129915 DG12129916 DG12129917 DG12129918 SG24700050 SGWZ01150227 SGWZ02150229 SGWZ02150230 SGWZ03150232 SGWZ04140102 SGWZ06140105 SGWZ10150251 SGWZ11140117 SGWZ11140119 SGWZ12130002 SGWZ16140130 SGWZ16140133 SGWZ17140136 SGWZ19140145 SGWZ20130007 SGWZ21140154 SGWZ24140160 SGWZ25140161 SGWZ29140169 SGWZ30140174 SGWZ31140176 SGWZ34130036 SGWZ39130046 SGWZ42130052 SGWZ42140205 SGWZ42140206 SGWZ43130054 SGWZ43140208 SGWZ43140209 SGWZ46140215 SGWZ46140216 SGWZ47140217 SGWZ47140218 SGWZ48130079 SGWZ50130085
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
  • Product Description
    WIZARD2 5-detector, 550 samples || Product Code: 2470-0050, 3470-0050 || The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
  • Manufacturer
    Perkinelmer

Manufacturer

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