Events

Recall of WIZARD2 GAMMA COUNTER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PERKINELMER HEALTH SCIENCES CANADA 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
    43413
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Manufacturer has become aware through a customer complaint that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024 and the wizard2 gamma counter scans the affected barcode label the protocol associated with barcode id #024 is executed. if the error is undetected the wizard2 gamma counter may produce erroneous results.

Device

WIZARD2 GAMMA COUNTER
  • Model / Serial
    Model Catalog: 2470-0150 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2480-0010 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0200 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0150 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0020 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0100 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0010 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 3470-0050 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 2470-0050 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    WIZARD2 GAMMA COUNTER
  • Manufacturer
    PERKINELMER HEALTH SCIENCES CANADA INC.

Manufacturer

PERKINELMER HEALTH SCIENCES CANADA INC.
  • Manufacturer Address
    WOODBRIDGE
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    HC