Recall of 1235 AUTODELFIA SYSTEM - PLATE PROCESSOR - CLASS 3

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
    82312
  • Event Risk Class
    II
  • Event Initiated Date
    2009-06-30
  • Event Country
  • 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
    Autodelfia software could not recognize the pre-dilution factor given for result calculation if used in connection with additional loading functionality. this restriction applied only to autodelfia systems equipped with sample processor that are using ad software version v2.0 or v2.0 rev2.

Device

  • Model / Serial
    Model Catalog: 10859806 (Lot serial: 2970765); Model Catalog: 1235-8070 (Lot serial: 2350931); Model Catalog: 10859806 (Lot serial: 2350931); Model Catalog: 10859806 (Lot serial: 2350944); Model Catalog: 1235-8070 (Lot serial: 2350944); Model Catalog: 10859806 (Lot serial: 2970768); Model Catalog: 1235-8070 (Lot serial: 2970768); Model Catalog: 10859806 (Lot serial: 2350928); Model Catalog: 1235-8070 (Lot serial: 2350928); Model Catalog: 10859806 (Lot serial: 2970761); Model Catalog: 1235-8070 (Lot serial: 2970761); Model Catalog: 10859806 (Lot serial: 2350943); Model Catalog: 1235-8070 (Lot serial: 2350943); Model Catalog: 10859806 (Lot serial: 2970771); Model Catalog: 1235-8070 (Lot serial: 2970771); Model Catalog: 10859806 (Lot serial: 2350946); Model Catalog: 1235-8070 (Lot serial: 2350946); Model Catalog: 10859806 (Lot serial: 2970769); Model Catalog: 1235-8070 (Lot serial: 2970765); Model Catalog: 1235-8070 (Lot serial: 2970769); Model Catalog: 1235-8070 (Lot serial: 2970786); Model Catalog: 10859806 (
  • Product Description
    AutoDELFIA Software v2.0 and v2.0 Rev2
  • Manufacturer

Manufacturer

  • Manufacturer Address
    WOODBRIDGE
  • Manufacturer Parent Company (2017)
  • Source
    HC