Events

Recall of DATA STATION AMPLILINK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

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
    116986
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-03
  • 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
    Potentiel situation where the symantec software manufacturer has identified that an it security issue could affect the pcanywhere software version 12.6.6 an older when used on several of the roche instrument plateforms which provide for access to pcs remotely. there is a potentiel risk that this access could be used by attackers to read change or delete critical information such as test results patient data and audit trail.

Device

DATA STATION AMPLILINK
  • Model / Serial
    Model Catalog: 03516440001 (Lot serial: NA); Model Catalog: 03245233001 (Lot serial: NA); Model Catalog: 03531414001 (Lot serial: NA); Model Catalog: 21045199001 (Lot serial: NA); Model Catalog: 12236931001 (Lot serial: NA); Model Catalog: 06541089001 (Lot serial: NA)
  • Product Description
    DATA STATION AMPLILINK
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC