Events

Recall of SPECIMEN GATE LABORATORY

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
    56344
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-07
  • 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
    There is a possibility that incorrect neonatal screening results could be reported incorrectly due to unintended change of data related to the manually calculated assays in specimen gate laboratory software.

Device

SPECIMEN GATE LABORATORY
  • Model / Serial
    Model Catalog: 5002-0180 (Lot serial: 1.8); Model Catalog: 5002-0180 (Lot serial: 1.9); Model Catalog: 5002-0180 (Lot serial: 1.3 Rev 2); Model Catalog: 5002-0180 (Lot serial: 1.9 Rev 2)
  • Product Description
    SPECIMEN GATE LABORATORY
  • Manufacturer
    PERKINELMER HEALTH SCIENCES CANADA INC.

Manufacturer

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